Posts Tagged Quality

JOBS: February, 2022


Senior R&D Mechanical Engineer – N. San Jose, CA

This is a very exciting opportunity to work at grounds level on a stealth mode project, with a veteran entrepreneur, with several successful prior ventures. Requires 8+ years of medical device product development experience and strong expertise in Solidworks.

Director of Quality Engineering – Alameda, CA

There is an exciting #JOB opportunity for Director of Quality Engineering, in Alameda, CA in a global medtech company focused on design, development & manufacturing of novel products to address unmet medical needs. 

Requirements include: Strong foundation in Quality, QE & Quality Management systems; Experience with growing & leading a high impact team; Proven record leading, mentoring, and developing Managers, Engineers; BS in engineering or related; 10+ years industry experience; 5+ years of people management experience. Also #medicaldevice experience, highly preferred.

Job Responsibilities: Provide leadership & drive quality results for company’s products; Ensure products are manufactured in a compliant manner; Risks are identified & mitigated during changes; New products are ushered into manufacturing in a timely manner, Work cross-functionally.

Assembler – San Jose, CA

There is an opening for an assembler with experience in assembling parts & components used in manufacturing medical devices. 

Requires fine hand dexterity; Understand Good Documentation Practices, GMP & CAPA; Ability to comply w/ work schedules, comply with safety practices & government regulations and follow Quality System procedures; Experience in writing notes, writing & updating assembly procedures, protocols & checklists; work collaboratively with QA & production management.

Requires: High School Diploma or equivalent; 2+ years medical device or pharma experience; good math & English skills.

Business Development Manager – San Jose, CA

There is an exciting opportunity for a Business Development Manager to support all aspects of business development initiatives including BD research & scouting to assess market developments and identify partnering opportunities; support business development transactions including due diligence, onboarding for R&D collaborations & licensing. This role will report to the VP of BD.

Responsibilities: Lead research & analysis of pharma landscape to identify strategic partner opportunities; Present internally; Identify, analyze & prioritize external innovation opportunities; Conduct market research & competitive analysis; Create financial models to support BD decision-making; Cultivate relationships within biotech community, attend conferences & trade shows; Support due diligence efforts, coordination, data room management and maintenance. 

Requirements: Excellent analytical, problem solving, organizational, communication & interpersonal skills; Min. BS degree PLUS 5+ years of BD experience preferably in pharma; Experience in financial modeling.

Senior Manufacturing Engineer – S. San Jose, CA

Bay Area start-up focusing on improving healthcare delivery through state-of-the-art catheter development has an immediate opening for senior manufacturing enginee, to support the development and production of innovative catheters ensuring high reliability, regulatory adherence, and cost-effective manufacturability.

Requirements: Minimum 10 years history of experience in medical device manufacturing environment; Proficiency in Solidworks; Experience writing protocols & test reports; Experience using inspection and test equipment (vision systems, tensile testing) are required.

Responsibilities: Support manufacturing activities; Spend time on the manufacturing line with the assemblers to improve processes & increase quality; Develop assembly & test fixturing; Create, validate & document new manufacturing processes; Write protocols & test reports; Prepare manufacturing lines for significant scale up; Conduct process verification & validation activities; Initiate failure analysis in manufacturing; Design, write & perform equipment qualifications & process validations; Facilitate transitioning development products to full scale production line; Collaborate with existing suppliers & bring up new ones with an eye towards partnership & efficiency. 

Director of Clinical Operations – N. San Jose, CA
Unique vascular startup with state of the art catheter development, with platform technology has an immediate opportunity to staff clinical and regulatory positions at all levels. Stay tuned for full JD – coming soon.

Research Scientist- Formulation and Pharmaceutics – San Jose, CA

Research Scientist – Formulations & Pharmaceutics – San Jose, CA

There is an immediate opportunity for senior and junior research scientists in formulations to work in a multi-disciplinary environment to address chronic diseases. 

Requirements

Experience in scientific experiments in formulation & process development of parenteral dosage forms; Experience in immediate & sustained release parenteral formulations; Understand advanced drug delivery systems & pharmaceutical applications, such as emulsions, suspensions, polymer, nanoparticle, PLGA microspheres and colloidal systems; Exp. in chemical & physical stability of formulations, maintain documentation; Ability to identify stability, manufacturability & performance issues, interpret scientific data, communicate effectively & present data; Participate in tech transfer from R&D to Manufacturing. Required MS in Pharmaceutical Sciences or related PLUS 1+ yrs bio/pharma industry exp. Highly preferred pharma formulation experience & Exp working with drug-device combination. 

Bioanalytical Scientist – N. San Jose, CA

There is an exciting immediate job opportunity for a bioanalytical scientist in San Jose, CA to work on novel drug device combinations for treating chronic diseases. There are three opportunities and position, salary and benefits will be commensurate with experience. This position will be involved in the development of in vitro/in vivo models by performing a variety of microplate assays; Configure, program and troubleshoot laboratory automated platforms; Optimize existing automated processes to improve efficiency, throughput, robustness and quality; Perform routine data management tasks; Support regulatory efforts; Perform other duties as assigned.

Requirements: BS with 2-5 years or MS with 0-3 years or Ph. D. with 2+ years of industry experience is required; Also required, Experience in preclinical & clinical research; experience in biochemical analysis such as spectrophotometric, fluorescence immuno assays, HPLC, CE, LC-MS; Experience with microplate assays; Hands-on experience in automation and liquid handling in a bioanalytical lab setting; Experience working with statistical software like Excel, GraphPad Prism and Softmax Pro; and Experience with writing reports/protocols and SOPs. Experience with Luminex MapX technology is an advantage.

R&D Scientist – N. San Jose

A drug delivery company with unique technology to deliver biologics has an exciting job opportunity in San Jose, CA for R&D Scientist.  

Requirements: BS/MS in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering or related; 5+ years pharma or biotech experience in biologics analytical development, particularly, experience in biophysical techniques and analytical characterization of peptides and proteins is a must. Candidates must have experience of working in GLP/GMP regulated environment and working knowledge in product formulation (solid oral dosage, and/or parenteral sustained release) and process development from early to late phase development or at minimum hands on experience in providing analytical support to these activities. Also required, knowledge of state of the art analytical techniques such as various HPLC modes and detections, LC-MS, CE-SDS, peptide mapping, ELISA, cell based assays etc for product characterization, comparability testing and PK/PD analyses. Experience in working with drug-device combination products is a plus.
Responsibilities:  Assessing chemical and physical stability of formulations and identifying appropriate stability, manufacturability, and performance critical quality attributes; Establishing and managing reference standard and stability programs; Participate in method and tech transfer from R&D to Manufacturing as appropriate; Writing, reviewing and approving CMC sections of regulatory filings; Assessing utilization of resources and identifying when, and where additional resources may be needed; Communicate effectively to the project team and present data at team meetings; Maintain high quality documentation of all activities in notebooks, Other duties as explained.

Molecular Biologist – South San Francisco, CA

An early stage biotechnology company located in S. San Francisco, CA has developed patented technology for engineering mammalian cells to vastly increase their productivity for therapeutic protein or virus production and has an exciting opportunity for senior molecular biologist. 

Requirements: Must have PhD in a related field or equivalent amount of experience with recombinant mammalian cell line creation; mammalian cell culture expertise; experience with general molecular biology techniques for designing and constructing vectors and transfecting mammalian cells; experience with protein assay techniques for screening transfected cells. Also highly preferred, Experience with flow cytometry, virology, cell banking, transposase transfection methods; experience with protein analytical methods; knowledge of the regulatory environment related to creating and testing cells destined for GMP manufacturing; and photomicroscopy.

Responsibilities: This position is responsible for helping develop the technology toward full commercialization. Responsibilities include work with cell engineering, vector design and construction, transfection, mammalian cell culture, cloning and screening, flow cytometry, and other related molecular and cellular biology techniques. 

Quality Assurance Engineer – North San Jose, CA

There is immediate opportunity for Quality Engineer in well funded startup by a veteran leader with a world class team to support compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for class II and class III medical devices and combination products. This position also ensures that the company complies with all applicable federal, industry, and company procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.

Responsibilities: Maintain and improve quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements; Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs; Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause; Lead the resolution of quality issues related to non-conformance reports and CAPAs; Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ); Provide QE support to production, purchasing and engineering; Support/lead test method validation activities; Conduct and support the development and validation of appropriate test methods for product and process performance; Develop and initiate sampling procedures and statistical process control methods; Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan; Address systemic quality issues with suppliers or internal groups; Oversee calibration and preventive maintenance program; Assist in the review of lot history records and disposition of product (subassembly and finished goods); Work with engineering to develop adequate inspection criteria; Perform statistical analysis such as capability, gage R&R, and statistical process control; Evaluate product changes for qualification and validation requirements and assist in change implementations.

Requirements: A minimum of 7 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device), Experience with FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971), Experience with non-conformances, CAPA, and Risk Management, Experience in performing test method validation and Gage R&Rs, Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes) and BS in Engineering is required. CQE, CQA preferred.

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JOBS – January, 2022


Office, Notes, Notepad, Entrepreneur, Hand, Secretary

Senior R&D Mechanical Engineer – N. San Jose, CA

This is a very exciting opportunity to work at grounds level on a stealth mode project, with a veteran entrepreneur, with several successful prior ventures. Requires 8+ years of medical device product development experience and strong expertise in Solidworks.

Senior Manufacturing Engineer – S. San Jose, CA

Bay Area start-up focusing on improving healthcare delivery through state-of-the-art catheter development has an immediate opening for senior manufacturing enginee, to support the development and production of innovative catheters ensuring high reliability, regulatory adherence, and cost-effective manufacturability.

Requirements: Minimum 10 years history of experience in medical device manufacturing environment; Proficiency in Solidworks; Experience writing protocols & test reports; Experience using inspection and test equipment (vision systems, tensile testing) are required.

Responsibilities: Support manufacturing activities; Spend time on the manufacturing line with the assemblers to improve processes & increase quality; Develop assembly & test fixturing; Create, validate & document new manufacturing processes; Write protocols & test reports; Prepare manufacturing lines for significant scale up; Conduct process verification & validation activities; Initiate failure analysis in manufacturing; Design, write & perform equipment qualifications & process validations; Facilitate transitioning development products to full scale production line; Collaborate with existing suppliers & bring up new ones with an eye towards partnership & efficiency. 

Director of Clinical Operations – N. San Jose, CA
Unique vascular startup with state of the art catheter development, with platform technology has an immediate opportunity to staff clinical and regulatory positions at all levels. Stay tuned for full JD – coming soon.

Bioanalytical Scientist – N. San Jose, CA

There is an exciting immediate job opportunity for a bioanalytical scientist in San Jose, CA to work on novel drug device combinations for treating chronic diseases. There are three opportunities and position, salary and benefits will be commensurate with experience. This position will be involved in the development of in vitro/in vivo models by performing a variety of microplate assays; Configure, program and troubleshoot laboratory automated platforms; Optimize existing automated processes to improve efficiency, throughput, robustness and quality; Perform routine data management tasks; Support regulatory efforts; Perform other duties as assigned.

Requirements: BS with 2-5 years or MS with 0-3 years or Ph. D. with 2+ years of industry experience is required; Also required, Experience in preclinical & clinical research; experience in biochemical analysis such as spectrophotometric, fluorescence immuno assays, HPLC, CE, LC-MS; Experience with microplate assays; Hands-on experience in automation and liquid handling in a bioanalytical lab setting; Experience working with statistical software like Excel, GraphPad Prism and Softmax Pro; and Experience with writing reports/protocols and SOPs. Experience with Luminex MapX technology is an advantage.

R&D Scientist – N. San Jose

A drug delivery company with unique technology to deliver biologics has an exciting job opportunity in San Jose, CA for R&D Scientist.  

Requirements: BS/MS in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering or related; 5+ years pharma or biotech experience in biologics analytical development, particularly, experience in biophysical techniques and analytical characterization of peptides and proteins is a must. Candidates must have experience of working in GLP/GMP regulated environment and working knowledge in product formulation (solid oral dosage, and/or parenteral sustained release) and process development from early to late phase development or at minimum hands on experience in providing analytical support to these activities. Also required, knowledge of state of the art analytical techniques such as various HPLC modes and detections, LC-MS, CE-SDS, peptide mapping, ELISA, cell based assays etc for product characterization, comparability testing and PK/PD analyses. Experience in working with drug-device combination products is a plus.
Responsibilities:  Assessing chemical and physical stability of formulations and identifying appropriate stability, manufacturability, and performance critical quality attributes; Establishing and managing reference standard and stability programs; Participate in method and tech transfer from R&D to Manufacturing as appropriate; Writing, reviewing and approving CMC sections of regulatory filings; Assessing utilization of resources and identifying when, and where additional resources may be needed; Communicate effectively to the project team and present data at team meetings; Maintain high quality documentation of all activities in notebooks, Other duties as explained.

Molecular Biologist – South San Francisco, CA

An early stage biotechnology company located in S. San Francisco, CA has developed patented technology for engineering mammalian cells to vastly increase their productivity for therapeutic protein or virus production and has an exciting opportunity for senior molecular biologist. 

Requirements: Must have PhD in a related field or equivalent amount of experience with recombinant mammalian cell line creation; mammalian cell culture expertise; experience with general molecular biology techniques for designing and constructing vectors and transfecting mammalian cells; experience with protein assay techniques for screening transfected cells. Also highly preferred, Experience with flow cytometry, virology, cell banking, transposase transfection methods; experience with protein analytical methods; knowledge of the regulatory environment related to creating and testing cells destined for GMP manufacturing; and photomicroscopy.

Responsibilities: This position is responsible for helping develop the technology toward full commercialization. Responsibilities include work with cell engineering, vector design and construction, transfection, mammalian cell culture, cloning and screening, flow cytometry, and other related molecular and cellular biology techniques. 

Quality Assurance Engineer – North San Jose, CA

There is immediate opportunity for Quality Engineer in well funded startup by a veteran leader with a world class team to support compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for class II and class III medical devices and combination products. This position also ensures that the company complies with all applicable federal, industry, and company procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.

Responsibilities: Maintain and improve quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements; Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs; Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause; Lead the resolution of quality issues related to non-conformance reports and CAPAs; Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ); Provide QE support to production, purchasing and engineering; Support/lead test method validation activities; Conduct and support the development and validation of appropriate test methods for product and process performance; Develop and initiate sampling procedures and statistical process control methods; Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan; Address systemic quality issues with suppliers or internal groups; Oversee calibration and preventive maintenance program; Assist in the review of lot history records and disposition of product (subassembly and finished goods); Work with engineering to develop adequate inspection criteria; Perform statistical analysis such as capability, gage R&R, and statistical process control; Evaluate product changes for qualification and validation requirements and assist in change implementations.

Requirements: A minimum of 7 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device), Experience with FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971), Experience with non-conformances, CAPA, and Risk Management, Experience in performing test method validation and Gage R&Rs, Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes) and BS in Engineering is required. CQE, CQA preferred

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JOBS – October, 2021


Reagent & Assay Development Research Associate – Santa Clara, CA

Female industrial worker working with manufacturing equipment in a factory Professional young industrial factory woman employee working with machine parts putting, checking and testing industrial equipments cables in large Electric electronics wire and cable manufacturing plant factory warehouse Laboratory Stock Photo

There is an exciting job opportunity for Reagent & Assay Development Research Associate in Sunnyvale, CA with a company developing innovative single-molecule detection & ultra-high sensitivity platforms based on its expertise in optofluidics, assay development, system integration and microsystem technologies. This product development infrastructure and suite of proprietary technologies are ideally suited for the robust development of advanced diagnostic products. Competitive compensation will include an opportunity to participate in equity.

Candidate Requirements: Hands-on experience in protein & nucleic acid biochemistry, bioassay development and spectroscopy/microscopy; BS/ MS in biochemistry, biophysics or bio-analytical chemistry with 0-2 years of industrial experiences (recent graduates welcome to apply). Strong understanding of biochemical & bio-analytical techniques for protein, nucleic acids and nanoparticles/biopolymer characterization is required.  Also preferred, hands-on experience in Fluorescence Spectroscopy/Microscopy, Protein Assays, Electrophoresis, Dynamic Light Scattering/Zeta Potential, UV-VIS Spectroscopy, Chromatography, qPCR); Some experience with immunoassays and nucleic acid assays.  Excellent foundation of data analysis procedures and knowledge of basic statistical concepts is ideal. Experience with reagent preparation for single-molecule detection techniques is a big plus.

Bioanalytical Scientist – N. San Jose, CA

There is an exciting immediate job opportunity for a bioanalytical scientist in San Jose, CA to work on novel drug device combinations for treating chronic diseases. There are three opportunities and position, salary and benefits will be commensurate with experience. This position will be involved in the development of in vitro/in vivo models by performing a variety of microplate assays; Configure, program and troubleshoot laboratory automated platforms; Optimize existing automated processes to improve efficiency, throughput, robustness and quality; Perform routine data management tasks; Support regulatory efforts; Perform other duties as assigned.

Requirements: BS with 2-5 years or MS with 0-3 years or Ph. D. with 2+ years of industry experience is required; Also required, Experience in preclinical & clinical research; experience in biochemical analysis such as spectrophotometric, fluorescence immuno assays, HPLC, CE, LC-MS; Experience with microplate assays; Hands-on experience in automation and liquid handling in a bioanalytical lab setting; Experience working with statistical software like Excel, GraphPad Prism and Softmax Pro; and Experience with writing reports/protocols and SOPs. Experience with Luminex MapX technology is an advantage.

R&D Scientist – N. San Jose

A drug delivery company with unique technology to deliver biologics has an exciting job opportunity in San Jose, CA for R&D Scientist.  

Requirements: BS/MS in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering or related; 5+ years pharma or biotech experience in biologics analytical development, particularly, experience in biophysical techniques and analytical characterization of peptides and proteins is a must. Candidates must have experience of working in GLP/GMP regulated environment and working knowledge in product formulation (solid oral dosage, and/or parenteral sustained release) and process development from early to late phase development or at minimum hands on experience in providing analytical support to these activities. Also required, knowledge of state of the art analytical techniques such as various HPLC modes and detections, LC-MS, CE-SDS, peptide mapping, ELISA, cell based assays etc for product characterization, comparability testing and PK/PD analyses. Experience in working with drug-device combination products is a plus.
Responsibilities:  Assessing chemical and physical stability of formulations and identifying appropriate stability, manufacturability, and performance critical quality attributes; Establishing and managing reference standard and stability programs; Participate in method and tech transfer from R&D to Manufacturing as appropriate; Writing, reviewing and approving CMC sections of regulatory filings; Assessing utilization of resources and identifying when, and where additional resources may be needed; Communicate effectively to the project team and present data at team meetings; Maintain high quality documentation of all activities in notebooks, Other duties as explained.

Molecular Biologist – South San Francisco, CA

An early stage biotechnology company located in S. San Francisco, CA has developed patented technology for engineering mammalian cells to vastly increase their productivity for therapeutic protein or virus production and has an exciting opportunity for senior molecular biologist. 

Requirements: Must have PhD in a related field or equivalent amount of experience with recombinant mammalian cell line creation; mammalian cell culture expertise; experience with general molecular biology techniques for designing and constructing vectors and transfecting mammalian cells; experience with protein assay techniques for screening transfected cells. Also highly preferred, Experience with flow cytometry, virology, cell banking, transposase transfection methods; experience with protein analytical methods; knowledge of the regulatory environment related to creating and testing cells destined for GMP manufacturing; and photomicroscopy.

Responsibilities: This position is responsible for helping develop the technology toward full commercialization. Responsibilities include work with cell engineering, vector design and construction, transfection, mammalian cell culture, cloning and screening, flow cytometry, and other related molecular and cellular biology techniques. 

Quality Assurance Engineer – North San Jose, CA

There is immediate opportunity for Quality Engineer in well funded startup by a veteran leader with a world class team to support compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for class II and class III medical devices and combination products. This position also ensures that the company complies with all applicable federal, industry, and company procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.

Responsibilities: Maintain and improve quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements; Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs; Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause; Lead the resolution of quality issues related to non-conformance reports and CAPAs; Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ); Provide QE support to production, purchasing and engineering; Support/lead test method validation activities; Conduct and support the development and validation of appropriate test methods for product and process performance; Develop and initiate sampling procedures and statistical process control methods; Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan; Address systemic quality issues with suppliers or internal groups; Oversee calibration and preventive maintenance program; Assist in the review of lot history records and disposition of product (subassembly and finished goods); Work with engineering to develop adequate inspection criteria; Perform statistical analysis such as capability, gage R&R, and statistical process control; Evaluate product changes for qualification and validation requirements and assist in change implementations.

Requirements: A minimum of 7 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device), Experience with FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971), Experience with non-conformances, CAPA, and Risk Management, Experience in performing test method validation and Gage R&Rs, Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes) and BS in Engineering is required. CQE, CQA preferred

Senior R&D Mechanical Engineer – N. San Jose, CA

This is a very exciting opportunity to work at grounds level on a stealth mode project, with a veteran entrepreneur, with several successful prior ventures. Requires 8+ years of medical device product development experience and strong expertise in Solidworks.

Senior Manufacturing Engineer – S. San Jose, CA

Bay Area start-up focusing on improving healthcare delivery through state-of-the-art catheter development has an immediate opening for senior manufacturing enginee, to support the development and production of innovative catheters ensuring high reliability, regulatory adherence, and cost-effective manufacturability.

Requirements: Minimum 10 years history of experience in medical device manufacturing environment; Proficiency in Solidworks; Experience writing protocols & test reports; Experience using inspection and test equipment (vision systems, tensile testing) are required.

Responsibilities: Support manufacturing activities; Spend time on the manufacturing line with the assemblers to improve processes & increase quality; Develop assembly & test fixturing; Create, validate & document new manufacturing processes; Write protocols & test reports; Prepare manufacturing lines for significant scale up; Conduct process verification & validation activities; Initiate failure analysis in manufacturing; Design, write & perform equipment qualifications & process validations; Facilitate transitioning development products to full scale production line; Collaborate with existing suppliers & bring up new ones with an eye towards partnership & efficiency. 

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JOBS – June, 2021


Office, Notes, Notepad, Entrepreneur, Hand, Secretary

Please see my current opportunities below. All opportunities are for local (US based) candidates with valid work visa with all required industry experience.  If you have an interest then please send an email (resume as an attachment) at wd under score darshana a&t hot mail or find me on Linkedin.

Senior Director/ VP of Regulatory Affairs – San Jose, CA

The position is independently responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams & will be responsible for managing all Regulatory Affairs activities (nonclinical and clinical) for investigational drug-device combination products from preclinical candidate designation through product approval, including regulatory submissions. Responsible for knowledge of regulatory requirements of major regions (US, EU, Japan and China) and for covering multiple development projects.

Major Duties and Responsibilities

  • Develop and execute regulatory strategies for earliest possible approvals for development programs.
  • Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
  • Set strategy for submissions of product registration documents to health authorities worldwide. Interact with other line functions in the preparation, review, and completion of documents for regulatory submissions.
  • Prepare submissions and regulatory filings of INDs, CTAs, BLAs, NDAs, MAA and other submission documents including meeting packages, briefing documents, responses, supplements etc.
  • Experience in CMC regulatory compliance to ensure CMC practices are carried out in agreement with regulatory agencies requirements and expectations
  • Review clinical trial documents including clinical protocols/reports, investigator brochures, nonclinical reports, protocols/test methods; review and approve clinical manufacturing plans and labeling, and authorize drug shipment to clinical sites.
  • Interact with regulatory agencies on defined matters. Liaise with regulatory agency project manager in coordinating meetings, providing responses to agency questions/requests.
  • Serve as Regulatory representative on project teams, manage regulatory timelines, and provide strategic input as applicable.
  • Interface with international affiliates on regional regulatory strategy and implementation of plans.
  • Effectively plan, organize, and conduct (or supervise) formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines.
  • Contribute to the development and maintenance the Regulatory Affairs working practices and procedures.

Education and/or Job Experience

  • Bachelor’s or Master’s degree in a scientific discipline.
  • 10-15 years’ experience in Regulatory Affairs in biotechnology & pharmaceutical industry.
  • Thorough knowledge of the drug, device and combination product development process with demonstrated experience in developing global regulatory strategy and submissions.
  • Experience in multiple phases of development in various therapeutic areas is desirable.
  • Experience with biologics is a must.
  • Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
  • Ability to communicate and interact effectively across departments and on project team(s).
  • Results driven and team-orientated, with the ability to influence outcomes.
  • Ability to travel

PROJECT MANAGER – San Jose, CA

We are seeking an experienced Project Manager to lead the successful execution and launch of engineering projects in a fast-paced environment.  The position has responsibility for daily management of complex projects and requires a high degree of coordination with a cross-functional team including Engineering, Manufacturing, Biology, Quality and Facilities.

Job Requirements

  • Oversee and drive multiple engineering projects of various size and complexity from initiation through validation and production release
  • Responsible for developing realistic project schedules, along with resource planning, risk management and measurable metrics to meet the project goals
  • Communicate progress to stakeholders including the executive leadership team and provide recommendations for mitigating risks or delays 
  • Coordinate interdependent tasks and deliverables with key stakeholders including R&D Engineering, Manufacturing & Process Engineering, Facilities, EH&S, and Quality Assurance
  • Lead and manage team meetings by creating agendas, presentations, minutes and action items. Document team decisions and follow up on action items and deliverables
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation 

Qualifications

  • BS degree in engineering or a related technical field
  • 7-10 years of experience with managing engineering projects and use of standard project management methodology, tools and/or software packages
  • The successful candidate will apply strong people and negotiation skills to plan, coordinate and execute all relevant activities in a phase- gate setting 
  • Excellent interpersonal skills with an ability to communicate to people at all levels of the organization
  • Strong leadership skills, self-motivated and ability to influence others to achieve successful outcomes 
  • The position requires a high degree of adaptability, flexibility, creative decision-making, and technical problem-solving abilities 
  • Excellent verbal, written, presentation and interpersonal skills
  • Must be able to handle multiple projects with exceptional organizational and time management skills
  • Proven experience using Project Management tools to manage complex project timelines as well as fluency with Excel, Word, PowerPoint and Visio 
  • Proven track record with Medical Device, FDA regulations, ISO, cGMP and QMS standards
  • In-depth understanding of verification & validation (IQ,OQ,PQ) as well as risk analysis (FMEA)

Preferred Qualifications

  • PMP certification
  • Experience with Visual Project Management 
  • Experience with turnkey, capital equipment
  • Familiarity with sterilization process and aseptic manufacturing

Travel

Up to 10%

Quality Assurance Engineer – North San Jose, CA

There is immediate opportunity for Quality Engineer in well funded startup by a veteran leader with a world class team to support compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for class II and class III medical devices and combination products. This position also ensures that the company complies with all applicable federal, industry, and company procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.

Responsibilities

Maintain and improve quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements; Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs; Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause; Lead the resolution of quality issues related to non-conformance reports and CAPAs; Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ); Provide QE support to production, purchasing and engineering; Support/lead test method validation activities; Conduct and support the development and validation of appropriate test methods for product and process performance; Develop and initiate sampling procedures and statistical process control methods; Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan; Address systemic quality issues with suppliers or internal groups; Oversee calibration and preventive maintenance program; Assist in the review of lot history records and disposition of product (subassembly and finished goods); Work with engineering to develop adequate inspection criteria; Perform statistical analysis such as capability, gage R&R, and statistical process control; Evaluate product changes for qualification and validation requirements and assist in change implementations.

Requirements

A minimum of 7 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device), Experience with FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971), Experience with non-conformances, CAPA, and Risk Management, Experience in performing test method validation and Gage R&Rs, Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes) and BS in Engineering is required. CQE, CQA preferred

Quality Engineer – South San Jose, CA

Exciting bay area start-up on catheter development to focus on improved outcomes of arterial disease has an immediate opportunity for a manufacturing minded Quality Engineer.

Responsibilities

Support QA/QC/QS functions and activities in a medical device manufacturing environment; Establish purchased materials RI acceptance criteria & perform RI; In-process/final device inspection; Technical Writing for Design History File documents etc, Regulatory & Quality System documents; Design, write & perform equipment qualifications & process validations; establish & maintain equipment calibration & maintenance; support team, contract manufacturers & suppliers with robust & statistically valid testing, sample size selection, monitoring & analysis requirements

Requirements

5+ years medical device work experience (vascular catheter exp preferred), formal statistics training, Validation protocol design & report writing exp, exp to work in & maintain compliance of a certified QMS related to configuration control, document control & change control, enthusiasm for producing cool new products for catheter development. College education preferred.

Bioanalytical Lab Research Scientist – San Jose, CA

This is an exciting opportunity for a bioanalytical scientist to join world class team to work on drug-device projects, with the potential to dramatically change patient outcomes. Position, salary, and benefits are commensurate with experience, with possibility of option grants!!

Required: Background in medical device or pharma testing & regulatory development. Experience in preclinical and clinical research is a must. The candidate must have technical training in biochemistry and/or pharmaceutical sciences with experience using lyophilization, Karl Fischer titration, and HPLC. Experience with biochemical analysis such as spectrophotometric and fluorescence immunoassays, and LC-MS is a plus. Also required, degree in biochem or pharma sciences w. 2+ years experience, extensive exp in various analytical techniques & bioanalytical assays.

Responsibilities: Lead projects on biologic formulation, drug product process development; Executes experiments based on protocols and implement; Develop & maintain documentation,  test methods, study protocols, SOPs, worksheets, forms, and reports; Design and manage data from complex experiments including preliminary statistical analysis; literature searches; Maintain lab & assay operations notebook, equipment, supplies, computer files; Support regulatory efforts.

Bioanalytical Lab Scientist – San Jose, CA

There is an exciting opportunity for a bioanalytical scientist to join a team working on drug-device combinations projects w/ potential to change patient outcomes. Attractive benefits package with competitive salary is offered and option grants makes this exciting opportunity. Perform literature search, routine data management, tabulate & graph results, support regulatory efforts & manage lab supplies, safety, equipment. 

Responsibilities: Perform bioanalytical assays for the quantification of the analytes in in-vitro, preclinical and clinical samples; Participate in the development of in vitro/in vivo models by performing a variety of microplate assays independently with minimal supervision; Configure, program and troubleshoot laboratory automated platforms; Optimize existing automated processes to improve efficiency, throughput, robustness and quality. Perform literature search, routine data management, tabulate & graph results, support regulatory efforts & manage lab supplies, safety, equipment.

Required: Background in medical device or pharma & exp in preclinical and clinical research is a must. Also required, background in biochemical analysis such as spectrophotometric, fluorescence immuno assays, HPLC, CE, LC-MS. exp w/ microplate assays is must and experience with Luminex MapX technology is a plus. BS + 3 yrs work exp or MS + 1 yr exp and exp in writing reports & SOPs, knowledge of statistical software like Excel, GraphPad, Prism & Softmax Pro and hands-on exp in automation & liquid handling in a bioanalytical lab is required.

Senior scientist role requires 5+ years work experience.

Senior Scientist/ Dir – S. San Francisco, CA

Senior Scientist/ Director/ VP (commensurate with experience)

An early stage biotechnology startup with patented technology for engineering mammalian cells to vastly increase productivity for therapeutic proteins & disrupt biologics manufacturing, has two exciting openings. (The company has backing from J&J).

Job Functions: The work will involve vector design & preparation, transfection, cell culture, cloning & screening, flow cytometry & other related molecular and cellular biology techniques. Collaboration with co-workers &  pharmaceutical company customers is essential for this position.

Requirements: Candidate is required to have Ph.D. plus multiple years of experience with cell line creation, mammalian cell culture expertise, know regulatory landscape related to creating & testing cells for GMP manufacturing; exp. with molecular biology techniques for creating vectors & transfecting cells: exp with protein assays, with a goal to further develop the technology toward full commercialization. Experience with flow cytometry, cell banking, transposase transfection methods a huge plus.

Manufacturing Engineer

There is immediate opportunity for Manufacturing Engineer in San Jose, CA, in a well funded startup by a veteran leader with a world class team.

Senior & Junior Mechanical Engineers – San Jose, CA

A bay area company with world class team, has an exciting opening for Senior & Junior Mechanical Engineers to design, develop & validate semi or fully automated equipment used for scale-up of high volume, disposable devices.

Responsibilities: Develop concepts & ideas for improving tooling, create new tooling, evaluate current manufacturing processes & workflows, take ownership of design, create User Requirements Specs, conduct concept reviews, show proof of concept through prototyping, support test data, coordinate with stakeholders for V&V, launch & documentation, created 3D models, engineering drawings & bills of materials, participate in design FMEA, plan to mitigate risks, and work with outside vendors, machine shops, contract manufacturers.
Requirements: BS in ME plus 3 to 13 years of medical device industry experience with complex mechanical/ electromechanical design, extensive experience with precision mechanisms pneumatics, servo systems, tooling/ fixtures, motors, belts/ pulleys, gears, actuators, sensors and experience creating engineering drawings, BOMs, products specs is required. Also required knowledge of material properties, heat treatment & surface finish, understanding of DFM & lean manufacturing, and track record with medical device manufacturing methods, RDA reqgulations, ISO, cGMP & QMS standards is required. MS in ME, experience with plastic injection molding, knowledge of DOE, SPC, JMP/ Minitab, experience with metal stamping, laser cutting, chemical etching, familiarity with sterilization process & aseptic environment and PLC programming would be a big plus.

Mechanical Engineer R&D – San Jose, CA

Senior Mechanical Engineer is responsible for evaluating and improving the current drug delivery system by testing and optimizing components or sub-assemblies as needed. He/she will work with quality & regulatory to develop complete documentation for the device.

Responsibilities: Evaluate current design & identify opportunities for improvement, show proof of concept through prototyping and supporting test data, document internal design control SOPs, lead V&V activities, create 3D models, engineering drawings & bill of materials, create work instructions & manufacturing SOP’s, work with quality, and outside vendors, machine shops, contract manufacturers and comply with company’s policies & guidelines regarding quality & regulatory.

Qualifications: BS in ME + 5 years hands’on experience in medical device design environment, experience with creating engineering drawings, BOMs, product specs, experience with implementing product into manufacturing, knowledge of FDA regulations & ISO, cGMP, QMS standards, understanding of DFM & lean manufacturing, experience with machine shop tools & SolidWorks. Master’s degree in ME or BME and/or experience with plastic injection molding, a huge plus.

Senior Catheter Design Engineer – S. San Jose, CA

There is an immediate opportunity for a Senior Catheter Design Engineer with 15 to 20 years experience in catheter design engineering in a stealth mode company that is less than 2 years away from getting its first two devices 510 K approved and launched. The company is led by a visionary leader and has highly experienced engineering and management team.  This a hug opportunity to participate at grounds level in what is a truly exciting and game changing technology that is poised to change the quality of care of cardiac patients, with a potential to save millions of healthcare dollars, on regular basis. Experience is IVUS engineering a huge plus.

Manufacturing/ Test/ Quality Engineer – S. San Jose, CA

A stealth mode cardiovascular company with experienced engineering team, led by a serial entrepreneur, has an immediate opening for  Manufaturing/ Test/ Quality Engineer. This requires 10 plus years experience in the filed of catheter engineering.

Catheter Design Mechanical Engineer – S. San Jose, CA

A stealth mode cardiovascular company, led by a serial entrepreneur with prior experience in building a company, has an immediate opening for  Catheter Design Mechanical Engineer. The position requires 5 to 10 years of experience in catheter engineering, a can do, problem solving attitude, excellent conflict resolution skills and an ability to handle uncertainty. 

Program/ Project Manager – S. San Jose, CA

A stealth mode cardiovascular company with world class engineering team, led by a veteran leader with prior experience in building a company, has an opening for  Program Manger with experience of working in catheter engineering industry and a demonstrated history of managing projects all the way from conceptualization, team building, cost estimation, implementation, regulatory 510 (K) approval, and production support to launch. Experience in catheter engineering and leading 510K approval program is absolutely essential.

Supply Chain Management/ Strategy Leader – S. San Jose, CA

A stealth mode startup with exciting technology with potential to alter the quality of care of cardiac patients is looking for Supply chain management/ strategy leader. This position requires extensive experience across the end to end supply chain spectrum in Class 3 medical device industry. It requires proven track record of significant contributions to cost reduction and productivity improvement and experience in cross-functional leadership.

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JOBS – March, 2021


Please see my current opportunities below. All opportunities are for local (US based) candidates with valid work visa with all required industry experience.  If you have an interest then please send an email (resume as an attachment). Please find me on Linkedin.

Home Office, Workstation, Office

Quality Engineer – South San Jose, CA

Exciting bay area start-up on catheter development to focus on improved outcomes of arterial disease has an immediate opportunity for a manufacturing minded Quality Engineer.

Responsibilities

Support QA/QC/QS functions and activities in a medical device manufacturing environment; Establish purchased materials RI acceptance criteria & perform RI; In-process/final device inspection; Technical Writing for Design History File documents etc, Regulatory & Quality System documents; Design, write & perform equipment qualifications & process validations; establish & maintain equipment calibration & maintenance; support team, contract manufacturers & suppliers with robust & statistically valid testing, sample size selection, monitoring & analysis requirements

Requirements

5+ years medical device work experience (vascular catheter exp preferred), formal statistics training, Validation protocol design & report writing exp, exp to work in & maintain compliance of a certified QMS related to configuration control, document control & change control, enthusiasm for producing cool new products for catheter development. College education preferred.

Quality Assurance Engineer – N. San Jose, CA

The Sr. Quality Assurance Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for pharmaceutical and combination products. This position requires technical expertise in Aseptic Techniques. The Senior Quality Engineer is responsible for performing a quality role for the aseptic manufacturing, quality systems and compliance in accordance with cGMP, related company SOP’s, federal laws, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products. 

Requirements

  • Maintain & improve company’s Quality System in accordance with FDA Regulations and ISO 13485 requirements
  • Provide hands-on direction for aseptic process and cGMP manufacturing activities 
  • Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs
  • Collaborate with cross functional teams Manufacturing, Engineering, Facilities to ensure adherence to cGMP guidelines
  • Conduct investigations for issues associated with audits, lot history records and complaints. Approve manufacturing and testing deviations and investigations 
  • Evaluation and support for implementation of new processes, lead continuous improvement of aseptic / sterile processes
  • Lead and support qualification and validation of cGMP equipment, facilities, utility systems, analytical test methods, cleaning and manufacturing processes. These duties will include, but are not limited to: the implementation and documentation of these validations and their lifecycle management in compliance with FDA and EU regulations
  • Manage the deviation system, perform QA assessment of deviations and ensure that all assessments are completed, review and approve deviation reports
  • Assist in the review and approval of lot history records and test records
  • Conduct audits at CMO, testing operations and internal audits
  • Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ), summary reports, ensure qualifications are conducted in accordance with the Validation Master Plan
  • Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
  • Lead the resolution of quality issues related to non-conformance reports and CAPAs
  • Develop and initiate sampling procedures and statistical process control methods
  • Address systemic quality issues with suppliers or internal groups
  • Evaluate product changes for qualification and validation requirements and assist in change implementations
  • Other duties/ activities may be necessary to support departmental or company goals

Qualifications

  • Bachelor’s degree or higher in Chemistry, Biology, or equivalent scientific discipline
  • A minimum of 7 years quality assurance/engineering experience within the pharmaceutical or biopharmaceutical industry is required
  • cGMP experience is required
  • Experience with performing utility qualification activities for vaporized hydrogen peroxide (VHP) system is preferred Excellent communication skills both oral and written
  • Understands and applies comprehensive knowledge of quality and GMP principles. Maintains current understanding of global GMP regulations
  • Experience with FDA Regulations (21 CFR part 820, part 210 and part 211) and ISO Standards (ISO 13485 and ISO 14971) is required
  • Experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)

Senior Quality Engineer – N. San Jose, CA

The Sr. Quality Assurance Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for class II and class III medical devices and combination products. This position also ensures that the company complies with all applicable federal, industry, and company procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.Requirements

  • Maintain and improve the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements
  • Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs
  • Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
  • Lead the resolution of quality issues related to non-conformance reports and CAPAs
  • Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
  • Provide QE support to production, purchasing and engineering
  • Support/lead test method validation activities
  • Conduct and support the development and validation of appropriate test methods for product and process performance
  • Develop and initiate sampling procedures and statistical process control methods
  • Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan
  • Address systemic quality issues with suppliers or internal groups
  • Oversee calibration and preventive maintenance program
  • Assist in the review of lot history records and disposition of product (subassembly and finished goods)
  • Work with engineering to develop adequate inspection criteria
  • Perform statistical analysis such as capability, gage R&R, and statistical process control
  • Evaluate product changes for qualification and validation requirements and assist in change implementations
  • Other duties/ activities may be necessary to support departmental or company goals

Education and Job Experience

  • A minimum of 7 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device,) is required
  • BS degree in Engineering is required
  • Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971) is required
  • Experience with non-conformances, CAPA, and Risk Management is required
  • Experience in performing test method validation and Gage R&Rs
  • Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
  • CQE, CQA preferred

Quality Engineer – South San Jose, CA

Exciting bay area start-up on catheter development to focus on improved outcomes of arterial disease has an immediate opportunity for Quality Engineer.

Responsibilities
Support QA/QC/QS functions and activities in a medical device manufacturing environment; Establish purchased materials RI acceptance criteria & perform RI; In-process/final device inspection; Technical Writing for Design History File documents etc, Regulatory & Quality System documents; Design, write & perform equipment qualifications & process validations; establish & maintain equipment calibration & maintenance; support team, contract manufacturers & suppliers with robust & statistically valid testing, sample size selection, monitoring & analysis requirements

Requirements
5+ years medical device work experience (vascular catheter exp preferred), formal statistics training, Validation protocol design & report writing exp, exp to work in & maintain compliance of a certified QMS related to configuration control, document control & change control, enthusiasm for producing cool new products for catheter development. College education preferred.

Director of Regulatory Affairs – San Jose, CA

  • This is an exciting opportunity to join a world class team working under veteran leadership on a game changing class 3 drug delivery combination medical device. This opportunity requires unique combination of experience with developing global regulatory strategy and submissions for combination product development plus experience in multiple phases of development in various therapeutic areas, plus experience with biologics. If you have the right experience, this is exciting and potentially high outcome opportunity that will not disappoint.
  • Bachelor’s or Master’s degree in a scientific discipline.
  • 10-15 years’ experience in Regulatory Affairs in biotechnology & pharmaceutical industry.
  • Thorough knowledge of the drug, device and combination product development process with demonstrated experience in developing global regulatory strategy and submissions.
  • Experience in multiple phases of development in various therapeutic areas is desirable. 
  • Experience with biologics is a must.
  • Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
  • Ability to communicate and interact effectively across departments and on project team(s).
  • Results driven and team-orientated, with the ability to influence outcomes.  

Bioanalytical Lab Research Scientist – San Jose, CA

This is an exciting opportunity for a bioanalytical scientist to join world class team to work on drug-device projects, with the potential to dramatically change patient outcomes. Position, salary, and benefits are commensurate with experience, with possibility of option grants!!

Required: Background in medical device or pharma testing & regulatory development. Experience in preclinical and clinical research is a must. The candidate must have technical training in biochemistry and/or pharmaceutical sciences with experience using lyophilization, Karl Fischer titration, and HPLC. Experience with biochemical analysis such as spectrophotometric and fluorescence immunoassays, and LC-MS is a plus. Also required, degree in biochem or pharma sciences w. 2+ years experience, extensive exp in various analytical techniques & bioanalytical assays.

Responsibilities: Lead projects on biologic formulation, drug product process development; Executes experiments based on protocols and implement; Develop & maintain documentation,  test methods, study protocols, SOPs, worksheets, forms, and reports; Design and manage data from complex experiments including preliminary statistical analysis; literature searches; Maintain lab & assay operations notebook, equipment, supplies, computer files; Support regulatory efforts.

Bioanalytical Lab Scientist – San Jose, CA

There is an exciting opportunity for a bioanalytical scientist to join a team working on drug-device combinations projects w/ potential to change patient outcomes. Attractive benefits package with competitive salary is offered and option grants makes this exciting opportunity. Perform literature search, routine data management, tabulate & graph results, support regulatory efforts & manage lab supplies, safety, equipment. 

Responsibilities: Perform bioanalytical assays for the quantification of the analytes in in-vitro, preclinical and clinical samples; Participate in the development of in vitro/in vivo models by performing a variety of microplate assays independently with minimal supervision; Configure, program and troubleshoot laboratory automated platforms; Optimize existing automated processes to improve efficiency, throughput, robustness and quality. Perform literature search, routine data management, tabulate & graph results, support regulatory efforts & manage lab supplies, safety, equipment.

Required: Background in medical device or pharma & exp in preclinical and clinical research is a must. Also required, background in biochemical analysis such as spectrophotometric, fluorescence immuno assays, HPLC, CE, LC-MS. exp w/ microplate assays is must and experience with Luminex MapX technology is a plus. BS + 3 yrs work exp or MS + 1 yr exp and exp in writing reports & SOPs, knowledge of statistical software like Excel, GraphPad, Prism & Softmax Pro and hands-on exp in automation & liquid handling in a bioanalytical lab is required.

Senior scientist role requires 5+ years work experience.

Pre-clinical Research Associate – San Jose, CA

This is an exciting opportunity to work with a world class team on a game changing technology. It requires specific in vivo research experience in animal biology, preferably with large (non-rodent) animal models and experience in one or more therapeutic areas: Gastrointestinal (GI), Central Nervous System (CNS), Cardiovascular (CV) and metabolic diseases.

Senior Scientist/ Dir (commensurate w exp)
S. San Francisco, CA

Senior Scientist/ Director/ VP (commensurate with experience)

An early stage biotechnology startup with patented technology for engineering mammalian cells to vastly increase productivity for therapeutic proteins & disrupt biologics manufacturing, has two exciting openings. (The company has backing from J&J).

Job Functions: The work will involve vector design & preparation, transfection, cell culture, cloning & screening, flow cytometry & other related molecular and cellular biology techniques. Collaboration with co-workers &  pharmaceutical company customers is essential for this position.

Requirements: Candidate is required to have Ph.D. plus multiple years of experience with cell line creation, mammalian cell culture expertise, know regulatory landscape related to creating & testing cells for GMP manufacturing; exp. with molecular biology techniques for creating vectors & transfecting cells: exp with protein assays, with a goal to further develop the technology toward full commercialization. Experience with flow cytometry, cell banking, transposase transfection methods a huge plus.

Manufacturing Engineer – San Jose, CA

There are two immediate opportunities for Manufacturing Engineer in N and S San Jose, CA. Both are in well funded startups by veteran leaders with a world class team of people. One is in a combination medical device and the other is in a cardio-vascular company.

Senior & Junior Mechanical Engineers – San Jose, CA

A bay area company with world class team, has an exciting opening for Senior & Junior Mechanical Engineers to design, develop & validate semi or fully automated equipment used for scale-up of high volume, disposable devices.

Responsibilities: Develop concepts & ideas for improving tooling, create new tooling, evaluate current manufacturing processes & workflows, take ownership of design, create User Requirements Specs, conduct concept reviews, show proof of concept through prototyping, support test data, coordinate with stakeholders for V&V, launch & documentation, created 3D models, engineering drawings & bills of materials, participate in design FMEA, plan to mitigate risks, and work with outside vendors, machine shops, contract manufacturers.
Requirements: BS in ME plus 3 to 13 years of medical device industry experience with complex mechanical/ electromechanical design, extensive experience with precision mechanisms pneumatics, servo systems, tooling/ fixtures, motors, belts/ pulleys, gears, actuators, sensors and experience creating engineering drawings, BOMs, products specs is required. Also required knowledge of material properties, heat treatment & surface finish, understanding of DFM & lean manufacturing, and track record with medical device manufacturing methods, RDA reqgulations, ISO, cGMP & QMS standards is required. MS in ME, experience with plastic injection molding, knowledge of DOE, SPC, JMP/ Minitab, experience with metal stamping, laser cutting, chemical etching, familiarity with sterilization process & aseptic environment and PLC programming would be a big plus.

Mechanical Engineer R&D – San Jose, CA

Senior Mechanical Engineer is responsible for evaluating and improving the current drug delivery system by testing and optimizing components or sub-assemblies as needed. He/she will work with quality & regulatory to develop complete documentation for the device.

Responsibilities: Evaluate current design & identify opportunities for improvement, show proof of concept through prototyping and supporting test data, document internal design control SOPs, lead V&V activities, create 3D models, engineering drawings & bill of materials, create work instructions & manufacturing SOP’s, work with quality, and outside vendors, machine shops, contract manufacturers and comply with company’s policies & guidelines regarding quality & regulatory.

Qualifications: BS in ME + 5 years hands’on experience in medical device design environment, experience with creating engineering drawings, BOMs, product specs, experience with implementing product into manufacturing, knowledge of FDA regulations & ISO, cGMP, QMS standards, understanding of DFM & lean manufacturing, experience with machine shop tools & SolidWorks. Master’s degree in ME or BME and/or experience with plastic injection molding, a huge plus.

Senior Catheter Design Engineer – S. San Jose, CA

There is an immediate opportunity for a Senior Catheter Design Engineer with 15 to 20 years experience in catheter design engineering in a stealth mode company that is less than 2 years away from getting its first two devices 510 K approved and launched. The company is led by a visionary leader and has highly experienced engineering and management team.  This a huge opportunity to participate at grounds level in what is a truly exciting and game changing technology that is poised to change the quality of care of cardiac patients, with a potential to save millions of healthcare dollars, on regular basis. Experience is IVUS engineering a huge plus.

Manufacturing/ Test/ Quality Engineer – S. San Jose, CA

A stealth mode cardiovascular company with experienced engineering team, led by a serial entrepreneur, has an immediate opening for  Manufaturing/ Test/ Quality Engineer. This requires 10 plus years experience in the filed of catheter engineering.

Catheter Design Mechanical Engineer – S. San Jose, CA

A stealth mode cardiovascular company, led by a serial entrepreneur with prior experience in building a company, has an immediate opening for  Catheter Design Mechanical Engineer. The position requires 5 to 10 years of experience in catheter engineering, a can do, problem solving attitude, excellent conflict resolution skills and an ability to handle uncertainty. 

Program/ Project Manager – S. San Jose, CA

A stealth mode cardiovascular company with world class engineering team, led by a veteran leader with prior experience in building a company, has an opening for  Program Manger with experience of working in catheter engineering industry and a demonstrated history of managing projects all the way from conceptualization, team building, cost estimation, implementation, regulatory 510 (K) approval, and production support to launch. Experience in catheter engineering and leading 510K approval program is absolutely essential.

Supply Chain Management/ Strategy Leader – S. San Jose, CA

A stealth mode startup with exciting technology with potential to alter the quality of care of cardiac patients is looking for Supply chain management/ strategy leader. This position requires extensive experience across the end to end supply chain spectrum in Class 3 medical device industry. It requires proven track record of significant contributions to cost reduction and productivity improvement and experience in cross-functional leadership.

Senior Technician/ Manufacturing Engineer – S. San Jose, CA

A stealth mode cardiovascular company, led by a serial entrepreneur with prior experience in building a company, has an opening for Senior Technician/ Manufacturing Engineer with 4 plus years experience in catheter engineering. 

NGS Research Scientist – Foster City, CA

Job Functions: To work on NGS assays for RNA seq, single cell and immune profiling projects & work collaboratively to develop new assays based on requests from the commercial team. Design & execute on NGS assays including 10X single cell & TCR/BCR repertoire profiling; Perform proof-of-concept experiments to enable development of new NGS applications for epigenetic and immunotherapy solutions; Collaborate w bioinformatics scientists to assist in data interpretation for single cell & TCR projects & generate presentations & reports for commercial projects; Generate data for application notes for marketing & BD needs.

Qualifications: Masters in Genetics, Immunology, Cancer Biology, Molecular Biology or related field; 2+ yrs NGS experience. Also, Hands-on experience in NGS techniques including sample extractions, RNA-seq, 10X, library prep & exp in low-input & single-cell NGS applications & exp in designing, executing, & troubleshooting for molecular & cell biology techniques a plus.

Mechanical Testing & Fixture Design  Engineer – Milpitas, CA

There is an immediate opening for mechanical testing and fixture design engineer. Good understanding of how to design and set up tests is required. Responsibilities include design unique tests, develop fixtures, report failtures, help improve manufacturing processes, support V&V testing, interface with manufacturing to implement new design updates into pilot manufacturing line and analyze data. BS in ME, fluency in SolidWorks, and 3-5 years of medical device industry experience is required.

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JOBS – June, 2016


All US based opportunities require valid US work visa and prior experience in biomedical industry.  Most of my current needs are in engineering and all engineering opportunities require medical device experience.  I have added some other opportunities in science, sales, BD etc.

I will be adding more opportunities.  If interested in any opportunities below, please send me an email (resume as an attachment) at wd_darshana at hot mail dot com and include position title in the subject line.  Please include in the email, how well the description matches your background and where the gaps are, if any.  All leads or referrals are greatly appreciated.

Director of Engineering – San Jose, CA
(Medical device implantable experience and hands-on engineering passion required).

Automatic Test Equipment Engineer – San Jose, CA
Immediately available.  Requires medical device experience. Send in resume ASAP.

Manufacturing Quality Engineer – San Jose, CA
Immediately available. Please send in resume ASAP.

Biochemist – San Jose, CA
Requires MS with 6+ years experience or PhD with 3 years experience in Biochem, Molecular Biology or related.  Immediately available, send in resume ASAP, if interested.

Quality Assurance Manager – San Jose, CA


Senior Manufacturing Engineer – San Jose, CA


Manufacturing Technician – San Jose, CA


Senior Mechanical Engineer – San Jose, CA

Biologist – San Jose, CA
Software Sales – San Jose, CA
Seed stage company offering a suite of subscription based software products, supported by cloud infrastructure, has an exciting opportunity for software sales professional, to join as member of the core founding team.  Although at pre-funding stage, the company is already generating revenues, with massive and growing database of products that can help scientists make environmentally friendly decisions throughout product development life-cycle.  Extensive customer relationship experience is required.  Familiarity with SciFinder, Reaxys etc. is required.   

Engineering Technician – Mt. Laurel, NJ

An innovative medical device company focused on treatment of cardiac diseases, has an exciting opening for Engineering Technician, in Mount Laurel, New Jersey.

Requirements: BS in EE, 3+ years experience as R&D Electrical Engineering Tech/ Testing Engineer, Prior experience in strongly regulated industries (e.g. medical, defense etc.), Prior experience with reliability tests and assembly.

Job functions:
* Conduct all assigned tests, under the direction of a senior engineer.
* Implement reliability test programs and test setups to implement test protocols.
* Conduct and document test protocols in component and system reliability, failure analysis, etc.
* Ensure compliance with regulations including QSR, ISO Standards and corporate policies.
* Specify and purchase components for test setups and prototypes.
* Procure and maintain engineering lab equipment in accordance with quality practices.

Senior Business Development Role – EU

Reporting To: Head – Global BD to manage all aspects of business development across the CRO portfolio of services; secure and retain business through professional, consultative & proactive sales activities directed at key decision makers.

Responsibilities:
Maintain knowledge of all appropriate cross-sell opportunities; Continued awareness of competitive activities, positioning & pricing; Work with regional & international counterparts to develop & close integrated opportunities; Analyze potential opportunities & develop sales plans for each target account; Develop in-depth knowledge of customer organization; Represent company at various industry conferences & trade shows; Prepare & lead sales presentation; Educate team in customer culture, operational needs/methods & sales techniques; Handle follow-up related to sale & drive completion of contract;  Maintain high visibility in customer organization; Monitor customer satisfaction; Record, plan & coordinate customer sales activities in CRM (SALESFORCE) system.

Requirements:  BS or MS in Life Sciences – PhD. preferred; 10+ yrs experience in BD / sales for CRO, CMO or related in life sciences; Ideally industry experience in combination of pharma or biotech in discovery research, CMC or commercial manufacturing technical roles; Solid understanding of drug discovery & development process; Track record of achievement in terms of sales goals; Experience working with international clients & colleagues; Ability to visualize & integrate company’s service portfolio across the drug development continuum;  Ability to cross-sell & credibly represent company services to clients; Ability to work from home-based office

Additional details: The position is located in EU.  Base pay: between 100,000 to 125,000 euros, car: 800 euros per month, VPP: 5% of base pay; Pension benefits: as applicable per country, Designation – Regional Director, BD

Analog Design & Embedded Systems Engineering Leader – San Jose, CA

Innovative, well funded bio-medical startup with disruptive technology has an exciting opportunity for analog design engineering leader, in San Jose, CA. Stock options, in addition to working on something truly exciting and life changing, would be a huge upside in this opportunity.  Requirements include, years of steady experience and passion for engineering problem solving, natural ability to take leadership role (MBA not required). This opportunity is immediately available and if you are engineering problem solver then it is one of the most exciting opportunities you may come across.  

Leads Engineer – Austin, TX or San Jose, CA

Requires BS in mechanical engineering, related to biomedical engineering and 10+ years medical device experience.  Highly desired, experience designing and developing medical products with implantable leads like cardiac pacemaker leads, proficiency in CAD, SolidWorks, and experience with MatLab, hands-on experience for fabricating prototype leads and related fixtures and tooling.

Responsibilities:   

  • Design and develop new conceptual leads in groundbreaking fields of medical devices.
  • Prototype lead designs and perform preliminary bench top testing
  • Develop processes for advanced lead designs
  • Develop, document, and implement test protocols for design verification and process validations
  • Design tooling for manufacture and assembly of implantable leads
  • Support in vivo and clinical evaluation of developed components

 

EMBEDDED SOFTWARE/FIRMWARE ENGINEER FOR MEDICAL DEVICES – Austin, TX or San Jose, CA

Requires: BS in Electrical or Software Engineering & 5+ years exp designing & developing embedded systems for medical devices; expertise in embedded C/C++, in optimization for performance & memory usage; exp developing apps that run a variety of OS/RTOS targets; working in structured environment w/ source control & bug tracking systems; exp developing low level device drivers for SPI, I2C, USB, LCD, ADC, DAC, exp with variety of CPU architectures (Arm Cortex M3/M4, TI MSP430 etc.; exp w/ board bring-up; effective use of hardware test equipment including logic analyzers, digital storage oscilloscopes, etc. Requires proficiency with Microsoft Office tools.

Responsibilities:
* Develop firmware for very low-power, battery powered systems consisting of a mix of analog, digital & RF circuitry in highly integrated, low power embedded designs
* Participate in design activities at architectural & implementation levels
* Design & implement error checking & fault handling, robustness & safety features
* Document software design & implementation
* Support V&V testing, work with V&V team to develop test plans & protocols
* Adhere to standards to help ensure compliance with FDA, ISO, AAMI & UL standards.

Director, Quality Assurance – Mt. Laurel, NJ
In the process of getting filled. 

 

Requirements include: Bachelors degree; 10-12 years experience in QA including medical device industry experience and supervisory/ management experience; & Good working knowledge of domestic & international requirements & regulations such as FDA, ISO, GMP etc.

Tasks:
* Work with contract manufacturer to ensure that devices are manufactured in compliance with US and international quality system requirements.
* Participate in product development teams on behalf of Quality Systems. Identify and resolve quality issues throughout product development process to assure successful audits and regulatory filings.
* Review all product complaints and ensure timely reporting of those events to domestic and international regulatory agencies as necessary.
* Schedule, conduct and assist in responding to internal audits , supplier audits and inspections.
* Maintain a functional CAPA system in compliance with applicable regulations
* Maintain ISO 13485:2003 facility registration in accordance with applicable standards.
* Provide guidance and supervision for Shipping/Receiving Clerk as it relates to completion of receiving inspections and other quality related functions.
* Ensure that the Quality Systems function is carried out in accordance with GMP and ISO directives.
* Review and revise quality system documentation to ensure compliance with domestic and international quality and regulatory requirements.
* Manage, supervise and train staff, oversee projects ongoing within departments, carry out departmental administrative duties.
* Schedule and complete timely management review presentations.
* Manage the document services function to ensure that quality systems documents, records and regulatory submissions are controlled.
* Manage product release and non-conforming product activities
* Maintain program to ensure adequate training of personnel on quality system documentation. Work with HR Department on companywide training activities.
* Ensure employees training on the Quality Systems Regulation and key international regulations and standards.
* Manage the program for handling product returns, returned product evaluations (and repair/rework, where applicable), complaints and customer feedback in accordance with internal policies and procedures.

Senior Clinical Research Monitor: Located anywhere (requires 80% travel)

Position Summary: Responsible for data quality & regulatory compliance at US clinical trial investigational sites. This responsibility is carried out by conducting on-site monitoring visits with Investigator & other research personnel.  Highly competitive salary.

Primary Responsibilities
* Orient site personnel to study protocol/procedures
* Monitor compliance to FDA Regulations & study protocol
* Monitor & promote compliance to local IRB reporting regulations
* Manage study site activities through frequent on-site visits
* Perform initial, interim & closeout study visits
* Communicate findings to investigators & study staff at the site
* Prompt reporting of compliance issues to in-house staff
* Follow-up on all outstanding issues to ensure each matter is addressed in a timely fashion
* Provide timely communication & written reports to the Clinical Affairs department after each monitoring visit

Additional Responsibilities
* Schedule on-site monitoring activities & travel in conjunction with company travel policies.
* May be required to supervise additional field monitors
* Up to 80% travel required.

Education and Experience Requirements
* This position requires a RN, BS, or similar degree (CRCC) with at least 5 years experience in monitoring clinical studies. The candidate must be very familiar with all FDA regulations governing IDE clinical trials.
* Experience in cardiac medical device related clinical trials
* Experience in clinical trial data management

Field Clinical Engineer (FCE) – Germany ( several locations: North Bavaria and Thüringen)

Requirements: BS in Engineering, Science or related; 5+years experience with use of invasive cardiovascular medical devices; knowledge of device-based cardiac rhythm & heart failure management; Prior experience working with clinical studies; Ability to quickly analyze & resolve clinical/technical issues; Frequent traveling to investigational sites, corporate offices, investigator meetings &  industry meetings.

Tasks:
* Develop a strong rapport with clinical sites by acting as consultants to support the site’s needs.
* Responsible for supporting all field-based activities at clinical sites.
* Drive enrollment by ensuring that investigational sites receive the necessary support in order to enroll, implant, and follow patients in a manner consistent with the clinical protocol.
* Support implant procedures and follow-ups at clinical sites
* Share clinical / technical experiences with other personnel in order to improve understanding of product behavior, improve product performance and product acceptance by customer.
* Communicate activities and issues at clinical sites with other company personnel
* Fulfill all administrative requirements including the collection of relevant technical data and completion of necessary documentation

Senior Electrical Engineer – Mt. Laurel, NJ – may be filled soon

An innovative medical device company focused on treatment of cardiac diseases, has an exciting opening for Senior Electrical Engineer in Mount Laurel, New Jersey.

Requirements: B.S. in EE; 5+ years experience as R&D EE in regulated industries (i.e Medical, defense, etc.); Applications development & PM experience; exp writing protocols, reports, regulatory documents; Understanding of patent applications & processes.  Exp in circuit design (Analog & mixed-mode circuits) & with digital signal processing algorithms, a big plus.

Tasks:
* Provide project leadership in product design & specifications, under direction of VP Product Development.
* Develop reliability tests programs &  setups to implement test protocols
* Work closely with vendors (i.e design subcontractors) on product requirements & specifications.
* Conduct design reviews & ensure compliance of design regulations including QSR, ISO standards and corporate policies.

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JOBS – November, 2015


Please see below some of my immediate opportunities. All opportunities are for candidates located in the United States only.  When sending your resume, please include details on your current compensation and compensation expectations.  Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com.

Research Associate/ Scientist – San Jose, CA
Innovative, well funded startup with novel drug-delivery technology has an immediate opening for research associate, in San Jose, CA.  
Requirements include, solid track record in bioanalytical assays.  Proficiency in HPLC, Elisa immunoassays, luminescence assays, fluorescence assays or related is required.  Experience in quantitative analysis, variability analysis in tissue and plasma, experience in pharmacokinetics, and experience in biologics a big plus.  Stocks and benefits make this a highly attractive opportunity to be involved in cutting edge technology, at grounds level.  

CLS Lab Manager – Santa Clara, CA

Minimum Qualifications:
The lab manager must possess an active, valid license issued by the State to perform high complexity testing pursuant to chapter 3 of Business and Professions Code or to practice medicine, osteopathy or podiatry pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties they are supervising; and– appropriate to the specialty or specialties for which they are consulting and, for the specialties of diagnostic immunology, chemistry, hematology, and microbiology, must–
(1) Have earned a bachelor’s degree in a chemical, physical or biological science or medical technology from an accredited institution; (CLS required)
(2) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty or subspecialty in which they supervise.

Duties and Responsibilities:
The lab manger shall be accessible to testing personnel at all times testing is performed by providing on-site, telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established either by the laboratory director.
The lab manager shall be responsible for ensuring that tests and examinations are performed in compliance with chapter 3 of the Business and Professions Code and Title 42, Code of Federal Regulations, Part 493 standards as published October 1, 1994, regarding clinical laboratories and–
(1) Be responsible for providing day-to-day supervision of high complexity test performance by a testing personnel;
(2) Be responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.
(3) Assure that all remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications;
(4) Ensure that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning;
(5) Provide orientation to all testing personnel;
(6) Ensure proper training and competency assessment of all supervised laboratory personnel;
(7) Ensure that Proficiency Testing procedures are followed as specified in Proficiency Testing Procedure;
(8) Timely review of all data and programs specified in the Quality Assessment Procedure as authorized

Project Manager with strong hands-on engineering plus bio background – Milpitas, CA

This is an exciting opportunity with a huge potential upside in stocks in a very innovative company with unique drug delivery technology.  
Strong technical background plus background in pharma chemistry and 10+ years experience with microsoft projects is ideal.  Drug-delivery device experience, a big plus.   

Director of Quality Engineering – Milpitas, CA

There is an immediate opportunity for Director of Quality Engineering.  It requires 10+ years experience in implantable device.  Some pharma experience highly desired.  Experience in implementing QE systems, a great plus.  This is very exciting opportunity to be involved in multiple projects with huge upside, in stocks potential.  Requires engineering background.

Director of Manufacturing Engineering – Milpitas, CA

There is immediate opening for Director of Manufacturing, that requires 10+ years experience in implantable devices.  Experience with injectible drugs, pills highly desired.  Strong hands-on expertise in tooling is required.  This is very exciting opportunity to be involved in multiple projects with huge upside, in stocks potential (a once in a lifetime kind of an opportunity).  

Post-doc opportunity – San Jose, CA

There are opportunities for some excellent post-docs for a drug delivery company.  These opportunities are for candidates with recent Ph.D. in Biochemistry or related and interest in obtaining exciting industrial post doc opportunity with exciting startup.

Senior Biochem Scientist- San Jose, CA

More details will be posted soon.  Meanwhile, candidates with strong drug delivery experience, please contact me.

Senior Quality Engineer – San Antonio, TX

Key Responsibilities
* Lead Quality Assurance for R&D- design, development, V&V phases including hazard/risk analysis and mitigation, DOE and related statistical design and analyses, GDT, design reviews, audits/compliance
* Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation
* Develop and implement QA systems to be compliant with applicable international and national standards such as ISO 13485 and regulatory requirements of FDA CFR 820 and other bodies for Class III implantables
* Implement productive relationships with R&D and manufacturing suppliers and partners
* Work in a matrixed organizational structure to support facilities in CA & TX.
* Educate colleagues and support in-house uptake and implementation of these systems organization-wide
* Support the following functions: o Regulatory Affairs o Intellectual Property
* Business and Commercialization, including due diligence documentation
* Implement documentation systems, including electronic systems, under the functional direction of QA Director
based in San Jose

Key Qualifications
* Designed and implemented QA systems for implantable medical devices and drugs. Combinatorial drug-device
and Class III experience desirable. At least 10 years experience, >15 years desirable.
* Bachelor’s degree in Engineering or in an equivalent field required, with ASQ certification (CQE, CRE, CQM, CSSBB) desirable
* Grown QA organizations with a hands-on, leadership- by-example and team-oriented approach
* Demonstrated working experience with electronics hardware and software, biomaterials, drugs, drug delivery, and mechanical technologies while supporting multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Excellent and demonstrated grasp and use of statistics in R&D and manufacturing including DOE • Supported multiple complex projects and start-ups
* Developed and implemented design controls, documentation, and design procedures, protocols
* Developed and implemented manufacturability, and related process flows and controls, and selected qualified vendors to manufacture Class II and III implantable devices
* Strong technical skills with demonstrated ability to provide hands-on solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator

Key Job Parameters
* Full-time position located in San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Senior Clinical Data Manager – Dublin, CA

Clinical Supplies Contractor – Dublin, CA

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JOBS — October, 2015


While the job report for this past month was dismal, I have some exciting opportunities.  Please see below some of my immediate opportunities. All US opportunities are for candidates located in the United States only.  But there are some new opportunities located in India (posted in August JOBS), for anyone wishing to do a stint in India, in very exciting, cutting edge multinational.  When sending your resume, please include details on your current compensation and compensation expectations.  Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com.

Director of Quality Engineering – Milpitas, CA

There is an immediate opening for VP of QE for exciting medical device company located in San Jose, CA.  It requires 10+ years experience in implantable device.  Some pharma experience highly desired.  Experience in implementing QE systems, a great plus.  This is very exciting opportunity to be involved in multiple projects with huge upside, in stocks potential.  Requires engineering background.

Director of Manufacturing Engineering – Milpitas, CA

Experience with implantable class III devices, tooling etc. highly desired.

VP of Engineering – Santa Clara, CA

There is an immediate opening for VP of Engineering for design services company, in Santa Clara, CA.

Requirements: Requirements include experience managing hardware and firmware projects including managing several teams of engineers, skill at interfacing with customers including outstanding communication skills & skill at quick understanding of the crux of a problem & solutions.  Although automated process is in place, candidate must have project management skills and experience.  Additionally, the candidate must have skill to understand the customer’s needs and desires, communicate them to engineers & to communicate back to the customer the opportunities & limitations in meeting their goals.

Sometimes, work starts early, before specifications are clear, as the company is called to do feasibility work to determine what can be done or how it can be done.  The company attempts to help customers become successful by requesting specifications or helping them write specifications that are clear and complete enough for senior engineers to complete the work with high quality, on time, and on budget.  It is highly desired to have design experience with hardware (analog or digital), firmware, or software.  It is desired to be skilled at writing proposals.  This is an opportunity to join a small team of high performing engineers and grow the staff as the company grows.

This is a rapidly growing product development company with a reputation for completing difficult projects on time and on budget.  The company designs devices, firmware, and software for other companies and has a track record to respond quickly, provide high quality work, and move on to other projects when done.  The company brings strong experience in working with sensors, wireless, and motion control.  Clients include companies making wearable devices, home health, products for the aging, medical devices, industrial devices, and others in fascinating and challenging fields.

Clinical PK Scientist – Dublin, CA

This position is responsible for overseeing the design, analysis, interpretation and reporting of pharmacokinetic, pharmacodynamic, drug disposition, and drug metabolism data from clinical studies for the oncology portfolio. 

Responsibilities: 

  • Responsible for performing pharmacokinetic analysis and PK and PK/PD modeling and simulations; contribute to relevant sections of Clinical Study Reports, Clinical Pharmacology related regulatory documents and draft relevant sections in support of clinical development plans, and provide Clinical Pharmacology and Pharmacometric perspective on cross-functional teams, including Clinical Study Teams
  • Plan and review study designs, analysis plans, data analysis, and interpretation of PK,  PK/PD, as well as planning, implementation and organization of regulatory filings and presentation of data at cross-functional teams, department meetings, conferences and regulatory meetings
  • Review PK/PD and bioanalytical data
  • Contribute to the design and development of ADME studies as well as the translation of these observations into an understanding of in vivo metabolic fate
  • Work closely with other scientists and disciplines (Biostatistics, Data Management, Translational Pharmacology, Pharmaceutical Development, CMC, Toxicology, Clinical Development, etc.) to plan, analyze and interpret the resulting PK, biotransformation and metabolism data

Qualifications:

  • PhD or equivalent in pharmacokinetics, pharmaceutics, pharmacology or similar area
  • Minimum 3 years’ experience – position title commensurate with experience
  • Hands-on experience with PK analysis and generating outputs gained within a pharmaceutical or biotechnology company
  • Experience with industry standard PK and PK/PD software and tools
  • Strong written, presentation, and verbal communication skills are essential

Post-docs – Engineering – ME, EE, Biochemistry, Pharmaceutical Sciences – CA & TX
Requires excellent and proven hands-on problem solving skills.

Senior Biochemistry Scientist – San Jose, CA
details to follow but feel free to send resume.

Biostatistical Programming Contractor/ Biostatistician – Dublin, CA 

This position will be responsible for providing quality programming & analysis support to the Biometrics & Data Management functions within the Clinical department, of oncology focused company, located in Dublin, CA. This is a contract position for an initial term of 12 months; onsite is strongly preferred but working remotely part time is negotiable.  More details will be posted soon.

Immediate contract Engineering Opportunities – San Jose, CA

  • Electrical Engineering & Software
  • Analog Design
  • PCB Layout (FR4, Flex etc.)
  • ASIC Design
  • Embedded Systems
  • TI MSP430, ARM, Cypress
  • Software (Windows, Linux, C++, Android, iOS)
  • Sensors
  • RF Communications
  • Bluetooth, Wi-Fi, 3G, 4G, GPS
  • Antenna Design
  • RF Test Labs
  • Test Engineering
  • Test Hardware & Software

Opportunities in India are posted in August JOBS posting.

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JOBS – April, 2015


Please see below opportunities and send resume as an attachment to wd_darshana at hotmail dot.  My imminent openings are for Senior Electrical, Mechanical, Quality and Software Engineering – all with strong medical device experience.  Please also notice contract opportunities at the end.  All US opportunities are for US based and local candidates.  When sending a resume, please mention job you are interested in, in the subject line and in the email include a brief summary of how best the job description matches your background and where the gaps are.

This is a photo symbolizing the job search in ...

This is a photo symbolizing the job search in today’s economy. Out of the darkness, there seems to be a ray of hope–but where? (Photo credit: Wikipedia)

Director of Mechanical Engineering – San Jose, CA
Requires 20+ years experience in polymers, balloons manufacturing. Complete details will be posted soon.

Mechanical Engineer – San Jose, CA
Requires 5+ years medical device experience.  Details will be posted soon.

Quality Engineer – San Jose, CA
Requires BS in Engineering and 10+ years medical device QE experience.  Details coming soon.

Physiologist – San Jose, CA
Requires large animals survival surgery experience.  Details coming soon.

Biochemist – San Jose, CA
Requires PhD + 3-5 years industry experience.  Details will be posted soon.

Ruby on Rails Engineer – San Mateo, CA

Senior Electrical Engineer – Austin/ San Antonio – TX

A company working on innovative range of products, has an immediate opening for senior electrical engineer with class III device experience.  Experience with closed loop, analog design hardware, microcontrollers, actuators  and ultra low power consumption circuit design highly desired.

Key Responsibilities
* Lead Electrical Engineering, primarily for long-term implantable drug delivery devices:
* on R&D- design and development of implantable and associated wearable and external hardware using mixed signal- analog and digital techniques, sensors and actuators and closed-loop control systems
* Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation esp for implantable electronics
* Develop Class III implantable electronics to be compliant with regulatory and QA standards (FDA and ISO), as well as be power-efficient, reliable for multi-year operation and pass EMI/RFI, be hermetically sealed and packaged and interface with rest of electronics systems for developed products
* Establish reliable suppliers and partners for manufacturing
* Work in a matrixed and multidisciplinary organizational structure to support multiple projects and technologies following appropriate QA system for each segment
* Document work output and use project and organizational documentation systems, including electronic systems
* Plan for and support existing and projected growth of the company.

Key Qualifications
* Designed and implemented electronics mixed-signal hardware, firmware and software for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. 10-15 15 years desirable
* Bachelor’s degree in Electrical Engineering or in an equivalent field required
* Led and grown EE groups with a hands-on, leadership- by-example approach
* Demonstrated working experience and accomplishments with electronics hardware and software- analog/digital, sensors/actuators. Developed, selected and qualified sensors for both implantable device function and for measuring physiological parameters
* Familiarity and experience with other implantable device components such as connectors, leads, cables, interconnects, headers, electronics packaging, communication protocols and standards. Real-time microcontroller programming a plus.
* Excellent and demonstrated grasp and use EDA tools: sensor/circuit design, simulation, layout. Hands-on re: circuit and system prototyping and development
* Developed and implemented manufacturability, and related process flows and controls. Selected and qualified vendors for manufacturing Class III implantable device electronics.
* Working knowledge of biomaterials, drugs, drug delivery, and mechanical technologies in support of multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Strong technical and hands-on skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator
* Supported multiple complex projects in a start-up environment: able to prioritize.

Key Job Parameters
* Full-time position located near Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Senior Design Engineer with Embedded Hardware & Firmware Skills – Santa Clara, CA

A reputed contract engineering company has an immediate full time opportunity for  a Senior Design Engineer with Embedded Hardware & Firmware Skills.  A rounded individual is desired who has an interest and ability in a wide range of technologies.  The successful candidate will lead a group of engineers from time-to-time and may be required to act as the primary interface to the customers at times.  The company designs devices, firmware, and software for other companies and has a reputation for quick response with high quality work.  The person must enjoy working with customers and have good communication skills.  The person must work well on a team of high performing engineers.  The person needs to be organized.  The person must work well with others and be flexible as schedules and priorities change.

Technical requirements: Ten years of experience in embedded system design engineering is required.  Ability to supervise others is highly desired.  The person should have experience designing circuits with microprocessors from PIC to ARM, FPGAs, Bluetooth, and WiFi as well as experience with programming in C or C++ on these devices.  The person must enjoy learning and be able to learn quickly.  The ability to design and program FPGAs is desired.
This could be a work-at-home job, or work at the company site, in Santa Clara, CA.

QUALITY ENGINEER – Santa Cruz, CA

See full description in March Job posting.

Senior Quality Engineer – Austin/ San Antonio – TX

A company working on innovative drug delivery technology has an immediate opening for senior quality engineer. Great opportunity to work at grounds level and grow into leadership role, in addition to the upside of stocks.

Key Responsibilities:
* Lead QA for: R&D- design, development, V&V phases including hazard/risk analysis and mitigation, DOE and related statistical design and analyses, GDT, design reviews, audits/compliance; Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation
* Develop and implement QA systems to be compliant with applicable international and national standards such as ISO 13485 and regulatory requirements of FDA CFR 820 and other bodies for Class III implantables
* Implement productive relationships with R&D and manufacturing suppliers and partners
* Work in a matrixed organizational structure to support company’s facilities, including the respective incubated companies, projects and technologies with an appropriate QA system for each segment
* Educate colleagues and support in-house uptake & implementation of these systems organization-wide* Support the following functions: Regulatory Affairs: provide appropriate documentation and materials to support filings for US and international trials and approvals; Intellectual Property: supporting documentation; Business and Commercialization, including due diligence documentation
* Develop & implement documentation systems for these business functions, including electronic systems, with help of to –be-hired Documentation Specialist

Key Qualifications
* Designed and implemented QA systems for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. At least 10 years experience, >15 years desirable*
* Bachelor’s degree in Engineering or in an equivalent field required, with ASQ certification (CQE, CRE, CQM, CSSBB) desirable
* Led and grown QA organizations with a hands-on, leadership- by-example approach
* Demonstrated working experience with electronics hardware and software, biomaterials, drugs, drug delivery, and mechanical technologies while supporting multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Excellent and demonstrated grasp and use of statistics in R&D and manufacturing including DOE
* Supported multiple complex projects and start-ups: able to prioritize.
* Developed and implemented design controls, documentation, and design procedures, protocols
* Developed and implemented manufacturability, and related process flows and controls, and selected qualified vendors to manufacture Class III implantable devices
* Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator

Key Job Parameters
* Full-time position located in Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Contract Opportunities with skills in following areas – San Jose, CA
* Electrical Engineering & Software
*  Analog Design
*  PCB Layout (FR4, Flex etc.)
*  ASIC Design
*  Embedded Systems
*  TI MSP430, ARM, Cypress
*  Software (Windows, Linux, C++, Android, iOS)
*  Sensors
*  RF Communications
*  Bluetooth, Wi-Fi, 3G, 4G, GPS
*  Antenna Design
*  RF Test Labs
*  Test Engineering
*  Test Hardware & Software
*  Manufacturing Engineering
* Fixture Design
*  DFM, DFT (Design for manufacturing, Design for Testability)
*  Process Development
* Machine Shop Support

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JOBS – March, 2015


Please see below opportunities and send resume as an attachment to wd_darshana at hotmail dot.  My imminent openings are for Senior Electrical, Mechanical, Quality and Software Engineering and for Technician – all with strong medical device experience.  Please also notice contract opportunities at the end.  All US opportunities are for US based and local candidates.  Opportunities exist in China that are open to all and you can see description in my previous blog at http://bit.ly/15STeDw specific one is for Director of Analytical R&D in Suzhou, China. When sending a resume, please mention job you are interested in, in the subject line and in the email include a brief summary of how best the job description matches your background and where the gaps are.

.jobs -- Cut To The Chase

.jobs — Cut To The Chase (Photo credit: Wikipedia)

Senior Electrical Engineer – Austin/ San Antonio – TX

A company working on innovative range of products, has an immediate opening for senior electrical engineer with class III device experience.  Experience with closed loop, analog design hardware, microcontrollers, actuators  and ultra low power consumption circuit design highly desired.

Key Responsibilities
* Lead Electrical Engineering, primarily for long-term implantable drug delivery devices:
* on R&D- design and development of implantable and associated wearable and external hardware using mixed signal- analog and digital techniques, sensors and actuators and closed-loop control systems
* Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation esp for implantable electronics
* Develop Class III implantable electronics to be compliant with regulatory and QA standards (FDA and ISO), as well as be power-efficient, reliable for multi-year operation and pass EMI/RFI, be hermetically sealed and packaged and interface with rest of electronics systems for developed products
* Establish reliable suppliers and partners for manufacturing
* Work in a matrixed and multidisciplinary organizational structure to support multiple projects and technologies following appropriate QA system for each segment
* Document work output and use project and organizational documentation systems, including electronic systems
* Plan for and support existing and projected growth of the company.

Key Qualifications
* Designed and implemented electronics mixed-signal hardware, firmware and software for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. 10-15 15 years desirable
* Bachelor’s degree in Electrical Engineering or in an equivalent field required
* Led and grown EE groups with a hands-on, leadership- by-example approach
* Demonstrated working experience and accomplishments with electronics hardware and software- analog/digital, sensors/actuators. Developed, selected and qualified sensors for both implantable device function and for measuring physiological parameters
* Familiarity and experience with other implantable device components such as connectors, leads, cables, interconnects, headers, electronics packaging, communication protocols and standards. Real-time microcontroller programming a plus.
* Excellent and demonstrated grasp and use EDA tools: sensor/circuit design, simulation, layout. Hands-on re: circuit and system prototyping and development
* Developed and implemented manufacturability, and related process flows and controls. Selected and qualified vendors for manufacturing Class III implantable device electronics.
* Working knowledge of biomaterials, drugs, drug delivery, and mechanical technologies in support of multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Strong technical and hands-on skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator
* Supported multiple complex projects in a start-up environment: able to prioritize.

Key Job Parameters
* Full-time position located near Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Senior Mechanical Engineer – Austin/ San Antonio – TX   &   San Jose, CA

A company working on innovative range of products, has an immediate opening for senior mechanical engineer with class III device experience at San Antonio, TX location and at San Jose, CA location.  See details below.

Key Responsibilities
* Hands-on support of Mechanical Engineering, primarily for long-term implantable drug delivery devices:
on R&D- design and development of implantable leads, cans, headers, and overall packaging and assembly of dynamic sensors, actuators, electronics and batteries for long-term (multi-year) use. Develop surgical tools and accessories for implantable systems.
* Manufacturing including materials (plastics, metals) and parts/system selection and qualification, process development: qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation especially for implantables
* Develop Class III implantables from all aspects of Mechanical Engineering to be compliant with regulatory and QA standards (FDA and ISO) including development and implementation of test fixtures and protocols
* Establish reliable suppliers and partners for manufacturing
* Work in a matrixed and multidisciplinary organizational structure to support multiple projects and technologies following appropriate QA system for each segment
* Document work and input into project documentation systems, including electronic systems
* Plan for and support existing and projected growth

Key Qualifications
* Designed and implemented long-term active implantable medical devices. Combinatorial device and Class III experience desirable. At least 10 years experience, >15 years desirable
* Bachelor’s degree in Mechanical Engineering or in an equivalent field required
* Led and grown ME groups with a hands-on, leadership- by-example approach
* Demonstrated working experience and accomplishments with implantable plastics and metals for connectors, leads, cables, interconnects, headers, electronics packaging, sensors/actuators, and batteries.
* Excellent and demonstrated grasp and use of ME computer-based tools and techniques: SolidWorks, FEA (thermal, strength/structure), 3-D modeling and printing
* Developed and implemented manufacturability, process flows and controls, and selected qualified vendors to manufacture Class III implantable devices using prototyping manufacturing as well as for mass-manufacturing
* Working knowledge of biomaterials, drugs, drug delivery, and electronics technologies and working on multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Strong technical and hands-on skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator
* Supported multiple complex projects in a start-up environment: able to prioritize.

Key Job Parameters
* Full-time position located near Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Senior Software/ Algorithm Engineer – Fremont, CA

A company providing innovative diagnostic & therapeutic products &  services to enable interventionalists in providing superior patient care, has an immediate opening for Senior Software Engineer, in Fremont, CA.  Position Summary: This position will be responsible for developing the next generation of image processing algorithms for company’s revolutionary medical devices for cardiovascular business. Individual will participate in object-oriented software development projects using C++ and Qt for a Linux environment. Communicate effectively, as well as to present information to a group in a professional manner. Work cooperatively as part of a team with people from various facilities and technical backgrounds.

Primary Duties and Responsibilities:
Design, develop, and optimize next generation image processing algorithms
Perform lab research and algorithm testing
Develop multi-threaded software for desktop applications
Design code for maintainability and unit tests
Identify, evaluate and mitigate technical project risks
Support formal verification and validation process and participates in transfer of products from R&D to manufacturing
Team player working in a geographically distributed team
Accurately estimate time and resources for completion of specific features/project
Assist in maintaining ISO certification and 510(k) submission requirements

Qualifications & Required Skills:
Minimum BS degree in Computer Science, Computer Engineering, Electrical Engineering, Applied Math, Biomedical Engineering, or related field; Strong background in image processing; 5+ years of software development experience; Excellent coding skills in C/C++; Proficiency in MATLAB; Experience designing object-oriented and distributed software; System level architecture design experienc; Experience with source code management systems like GIT, SVN, Clear Case

Preferred
Experience developing software for medical device applications for user interaction and control
Experience with medical imaging algorithms like segmentation, co-registration, 3d reconstruction
Experience with python, DICOM, OpenGL graphics
Other: * Travel requirements are moderate. Travel to facilities would be about 2 – 3 days duration each trip with total travel expected to be less than 20%.

Please submit resume at wd_darshana at hotmail dot com, with answers to following questions in the email.  This is client HR’s requirement. 
Please provide information on your formal education:
Please describe your software engineering experience as it relates to design, proof-of concept, detailed design, code, unit and integration testing:
Please describe your experience utilizing UML modeling language, DiCom, MFC, BOOST, STL and C++ :
Do you have experience working Linux OS environment? If yes, provide more detailed information:

Senior Design Engineer with Embedded Hardware & Firmware Skills – Santa Clara, CA

A reputed contract engineering company has an immediate full time opportunity for  a Senior Design Engineer with Embedded Hardware & Firmware Skills.  A rounded individual is desired who has an interest and ability in a wide range of technologies.  The successful candidate will lead a group of engineers from time-to-time and may be required to act as the primary interface to the customers at times.  The company designs devices, firmware, and software for other companies and has a reputation for quick response with high quality work.  The person must enjoy working with customers and have good communication skills.  The person must work well on a team of high performing engineers.  The person needs to be organized.  The person must work well with others and be flexible as schedules and priorities change.

Technical requirements: Ten years of experience in embedded system design engineering is required.  Ability to supervise others is highly desired.  The person should have experience designing circuits with microprocessors from PIC to ARM, FPGAs, Bluetooth, and WiFi as well as experience with programming in C or C++ on these devices.  The person must enjoy learning and be able to learn quickly.  The ability to design and program FPGAs is desired.
This could be a work-at-home job, or work at the company site, in Santa Clara, CA.

QUALITY ENGINEER – Santa Cruz, CA

Summary:  Medical device design and manufacturing company, located near Santa Cruz, CA, focusing on custom injection molded plastic parts, has an immediate opening for Quality Engineer.  Position focus is on providing support in the development and maintenance of company’s quality systems, support activities related to the development and qualification of new product development for medical device components and assemblies as well as supporting existing products.
Responsibilities
* Write FMEAs, review and write protocols and reports for new products
* Ability to multitask on a variety of Quality System compliance and improvement initiatives in a hands-on dynamic environment and be involved with the design, procurement, validation and qualification activities including test, inspection and medical device contract manufacturing service processes.
* Responsible for the facility measurement equipment calibration and maintenance program.
* Collects, collates and analyzes manufacturing data for warranty and nonconformance to determine and report product quality trends.
* Conducts analysis of inspection and tests of a routine degree of complexity and provides recommendations accordingly. Develops quality control inspection requirements and techniques to achieve measured improvement. * Implements the Failure Analysis Process for internal and external nonconforming product to determine appropriate corrective action.
* Support Receiving, In- process and Final Inspection of various components and subassemblies for medical device products to support quality compliance and shipment goals as workload requires.
* Assist in the development and implementation of Quality System processes.
* Attend various product meetings with Engineering, Sales, Support, Marketing, and customers to address product requirements, customer concerns and training issues. Work toward and support Company/Department/Team goals including; QSR and ISO compliance, revenues, training utilization, customer satisfaction, and others as appropriate.
* Qualify and implement document changes involving product or process changes
* Coordinate the reporting, analysis, and resolution of material non-conformance incidences
* Provide support in the timely resolution of product complaints and/or safety issues
* Conduct quality audits and develop subsequent preventive action programs
* Assist Regulatory Affairs Department in the preparation of audits and reports for regulatory agencies.
* Perform Supplier Quality Audits and, as appropriate, Internal Quality System Audits; identify root cause of non-compliance and ensure timely/effective corrections and lor corrective preventative actions are implemented
* Drive effective root cause corrective action through internal and supplier surveillance and corrective action requests.
* Report MRB performance metrics and maintain corrective action database.
* Review and report in-process data from manufacturing processes and facilitate corrective and preventive actions

Requirements: 5 – 7 years’ experience in Quality, medical device, regulatory, and or a medical device manufacturing environment; BS in Bachelor of Science in Quality, Business, Mechanical Engineering, Engineering or related field; Certification, CQE, CQA a plus; Experience as an ISO Lead Auditor desirable; Must be able to communicate effectively at varying technical levels with a customer audience; Hands-on manufacturing experience in mechanical or medical device assemblies. CMM, MicroVu, Vision Systems Programming experience; Working knowledge of U.S. and international medical device regulations is desirable Working knowledge of desktop computer office software, Visio Tools, CAD software and e-mail is required; Excellent verbal and written communication skills; Flexibility to handle multiple tasks and meet timelines; Excellent analytical and problem-solving skills combined with a strong technical presence.

Senior Quality Engineer – Austin/ San Antonio – TX

A company working on innovative drug delivery technology has an immediate opening for senior quality engineer. Great opportunity to work at grounds level and grow into leadership role, in addition to the upside of stocks.

Key Responsibilities:
* Lead QA for: R&D- design, development, V&V phases including hazard/risk analysis and mitigation, DOE and related statistical design and analyses, GDT, design reviews, audits/compliance; Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation
* Develop and implement QA systems to be compliant with applicable international and national standards such as ISO 13485 and regulatory requirements of FDA CFR 820 and other bodies for Class III implantables
* Implement productive relationships with R&D and manufacturing suppliers and partners
* Work in a matrixed organizational structure to support company’s facilities, including the respective incubated companies, projects and technologies with an appropriate QA system for each segment
* Educate colleagues and support in-house uptake & implementation of these systems organization-wide* Support the following functions: Regulatory Affairs: provide appropriate documentation and materials to support filings for US and international trials and approvals; Intellectual Property: supporting documentation; Business and Commercialization, including due diligence documentation
* Develop & implement documentation systems for these business functions, including electronic systems, with help of to –be-hired Documentation Specialist

Key Qualifications
* Designed and implemented QA systems for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. At least 10 years experience, >15 years desirable*
* Bachelor’s degree in Engineering or in an equivalent field required, with ASQ certification (CQE, CRE, CQM, CSSBB) desirable
* Led and grown QA organizations with a hands-on, leadership- by-example approach
* Demonstrated working experience with electronics hardware and software, biomaterials, drugs, drug delivery, and mechanical technologies while supporting multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Excellent and demonstrated grasp and use of statistics in R&D and manufacturing including DOE
* Supported multiple complex projects and start-ups: able to prioritize.
* Developed and implemented design controls, documentation, and design procedures, protocols
* Developed and implemented manufacturability, and related process flows and controls, and selected qualified vendors to manufacture Class III implantable devices
* Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator

Key Job Parameters
* Full-time position located in Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development

Electro-Mechanical Technician – Fremont, CA

A company that develops advanced injection technologies to simplify the complexities of the cardiac cath lab, has an immediate opening for R&D technician.

Requirements
* 9 years of electromechanical technician experience
* 2 year Technical School degree in electromechanics or related field or a combination of education and experience
* 2 years of computer aided design experience
* 2 years experience directing and leading the work of others
* Problem solving skills with the ability to interpret drawings, schematics, and specifications
* Experience using CAD-3D Modeling
* Effective verbal and written communication skills
* Moderate level of computer experience including MS Office Suite and SolidWorks
* Demonstrated experience using a multimeter, soldering iron, oscilloscope, and spectrum analyzer
* High degree of organization skills and high attention to detail
* Ability to prioritize and handle multiple tasks
* Ability to work independently with limited supervision
* Proficient at specifying and evaluating electrical components based on performance, lifetime, and availability
* Demonstrated project management experience
* Demonstrated test report-writing experience

Preferred
* 4+ years of computer aided design experience, * SolidWorks Proficient, * Experience providing technical support to circuit board manufacturing assembly, * Demonstrated knowledge of and familiarity with embedded systems and RF electronics, * Product development experience in a federally regulated engineering environment (FDA, ISO), * Experience defining, writing, and conducting test plans and reports.

Job Description & Responsibilities
Performs specified electromechanical engineering support activities under the guidance of an Engineer or Technical lead related to electro-mechanical design of medical device technologies, product and performance testing, and continuous improvement of the product design. The position is responsible for design, fabrications, assembly, validation, and implementation of development products and fixtures to support the design transfer of products into manufacturing operations.

Primary Duties and Responsibilities:
* Designs fixtures and test methods for validating product design and performance. Responsible for managing the ordering and delivery of fixture components and items from vendors or the internal Model Shop.
* Executes testing and validation protocols, records and analyzes data, and provides written reports to engineering team.
* Supports Product Development efforts at early stages up to design transfer. Provides support to engineers throughout the implementation and development cycles.
* Performs hands on activities such as design validation, pre-production assembly, testing and other technical activities to assist in product development.
* Assists engineers in identifying and resolving hardware design issues. Diagnoses the cause of electrical failures of circuit boards and operational equipment.
* Uses Solid Works CAD system to sketch and design fixtures and devices ensuring form, fit and functional requirements are met. Responsible for basic analysis of design in partnership with an Engineer.
* Responsible for initiating documentation changes and providing redlines to maintain the product information structure. Communicates issues and opportunities to engineering department to ensure bill of material (BOM’s), prints, process, forms, records, etc. are relevant and up to date.

Technical Engineering Support:
* Partners with Designers and Engineer, to develop and improve products, designs, fixtures, and process activities in the interest of continuous improvement and establishment of a Lean environment.
* Initiates design changes and coordinates the change order process to release product per the company’s Quality Management system. Responsible to maintain the design and information structure for use in the ERP system and engineering data base (PDM) DB Works. e.g.; BOM’s, prints, process, forms, records etc.
* Implements changes and maintenance of PDM and CAD systems as required. Assists IT and Technical Documentation Writer in annual CAD system updates, user rights management, and data base management. Creates and edits DB-Works and Solid Works API programs.

IF interested, please send resume with answers to the questions below. The client will only accept resumes, if the questions are answered.
Describe your formal education:
Describe your experience working in medical device or a regulated environment.
Give an example of a work situation where you had minimal supervision and it was critical to work within a fluid or flexible environment.
Describe your experience with developing test fixtures and methods to evaluate a product and/or technology.
Describe your experience developing or using different types of CAD models (or Computer-Aided Design), electrical schematics, or other types of models. (New Q)
Give an example of a product and/or technology project where you had to apply both mechanical and electrical/electronic skills.

 

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