Jobs – May, 2022

R&D Engineer w/ Analytical Instrumentation, Systems Integration Exp – Sunnyvale, CA

There are several exciting opportunities for product development research associate/ technician/ engineers in developing, testing, optimizing and troubleshooting aspects related to novel diagnostics technology platform & to work with novel detection systems, complex fluidic systems and assay optimization on prototypes and automated systems. The compensation will be competitive and includes stock with a huge potential as well as competitive benefits package. Company is found by a veteran leader and focuses on development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics & bioanalytical applications. This role requires working with a multidisciplinary team of engineers, scientists and manufacturing personnel. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human patient fluid samples. Other activities might be conducted in a CER (controlled environment) setting.

Responsibilities

Testing, development and optimization of functional biochips, fluidic cartridges & analytical instruments; Support document prep; Use Good Documentation Practices (GDP) while authoring Experimental summaries, DOPs, SOPs, batch records (BRs) and forms (FRs) for various unit operations; Process development & optimization related to biomolecular sensing; Support all aspects of technology transfer to & from development partners; Develop, test & execute QC procedures; Process troubleshooting to determine root cause & find possible engineering solutions.

Requirements: MS in bio-, mechanical-, electrical- or chemical engineering, chem or biochem, or related; 5+ years hands-on R&D, engineering or product development and project/ people management experience. Experience in developing custom equipment by collaborating with external vendors or internal engineering resources; hands-on experience in mechanical design and in building & operating electronic systems; Proficiency in CAD design; Experience w/ statistical analysis software as well as with instrument-oriented programming language(s) (e.g. Python; LabView); Experience with standard biotech laboratory and/or manufacturing equipment & working with biological or biochemical systems (e.g. proteins, nucleic-acids, cells and/or bio-organic molecules); Experienced using diverse analytical instruments e.g. oscilloscopes, DAQ interfaces; Experienced in cGMPs & in authoring DOPs, BRs, FRs; Experience in V&V of instruments and processes; and Knowledge of data analysis methods.

Optics & Photonics Research Scientist/ Engineer w/ microfluidics/ lab-on-a-chip Exp – Sunnyvale CA

This is an exciting opening for interdisciplinary research scientist/ engineer with experience in photonics, material science and/or biological applications product development to work in multi-disciplinary team, in developing, testing, optimizing and troubleshooting aspects related to novel diagnostics technology platform & to work with novel detection systems, complex fluidic systems and assay optimization on prototypes and automated systems. The compensation will be competitive and includes stock with a huge potential as well as a competitive benefits package. Company is founded by a veteran leader & focuses on development & commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics & bioanalytical applications. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human patient fluid samples. Other activities might be conducted in a CER (controlled environment) setting.

Responsibilities: Support optofluidic platform technology development, & development of single-molecule detection technology with novel reagents & fluidic cartridges, as well as instrumentation for detection, sample preparation & corresponding software; Support diverse aspects related to mid-stage development of a bio-chip based, optofluidic diagnostics platform; Apply diverse knowledge of design principles, practices & implementation in complex systems & assignments; Design, optimize, test, & support validation of optofluidic chips, optical/fluidic interfaces, sample processing technology & instruments, in collaboration with other groups & external suppliers; Develop, evolve & maintain custom optoelectronic systems used for testing and characterizing optofluidic systems; Analyze & present data including images, time traces, assay flows, optical spectrums; Conduct statistical analysis & build/implement/test models for stochastic, high-volume data; Support all aspects of technology transfer to and from internal and external partners; Interface with internal resources and external vendors to design, test & validate equipment.

Requirements: BS/ MS in bio-, mechanical-, electrical- or chemical engineering, chemistry, physics, biochemistry, or related plus 1-5 years hands-on R&D or engineering experience; Extensive theoretical and hands-on experience in optics/photonics; Experience bridging the fields of photonics/optical engineering, microfluidics/lab-on-a-chip & statistics; Exp in design of optical systems (free space & chip based) & in using simulation software eg. ray tracing software for system design & FEM/FDM/BPM etc for chip design: Proficiency in statistical analysis (e.g. Python, JMP, Matlab, etc.) as well as instrument-oriented programming language(s) (e.g. Python; LabView); Experience in using diverse, analytical instruments such as oscilloscopes, DAQ interfaces, UV-VIS spectrometers, scanning electron microscopes (SEMs), fluorescence microscopes, etc. Expertise in optofluidics, Hands on ability to work-with/manipulate/couple optical fiber and respective components, Proficiency with digital/analogue signals & systems; Experience simulating in Multiphysics environments (e.g. Comsol, Lumerical) and Circuit design and simulation experience are all HUGE PLUSES.

Finally, ONLY CANDIDATES PROVIDING A POSITION SPECIFIC COVER LETTER WILL BE CONSIDERED!

Software Engineer  w/ experience building products in multi-disciplinary envt – Santa Clara, CA

This is an exciting opening software engineer with experience software & hardware development to design, develop & implement a growing suite of bioanalytical solutions comprised of integrated biochips, proprietary reagents & custom instrumentation. The company is founded by a veteran leader and is developing single molecule detection technology, and is focusing on development & commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics & bioanalytical applications. 

Responsibilities: Lead / Support Software, Firmware & UI development aspects related to the development of novel, diagnostic instrument platforms; Develop control/analysis software for RUO (Research Use Only) & FDA regulated instrumentation; Develop / Contribute to a custom user interface for scientific & medical diagnostic systems; Support all aspects of technology transfer to & from internal & external partners; and work with a multidisciplinary team of experts.

Requirements: B.S. with 3+ years of relevant experience (Level I), B.S./M.S. with 7+ years of relevant experience. (Level III). Requirements also include, Significant experience with instrument-related software engineering using C#; Experience with Python programming; Exp w/ industry coding best practices (Git management, unit testing, documentation, etc; Experience developing, implementing, consuming & supporting contracted APIs. Also preferred: Experience with interface standards (e.g. GraphQL, OpenAPI, etc.); Experience with firmware level interaction (e.g. C). Experience with delivering quality conformant software (e.g. SaMD); Experience with complex data analysis challenges; Ability to develop custom equipment with external vendors and/or internal engineering resources.

Finally, ONLY CANDIDATES PROVIDING A POSITION SPECIFIC COVER LETTER WILL BE CONSIDERED!

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. 

Associate Director/Director Validation – SJ  /QUALITY – QA TEAM

There is an immediate opportunity for Director of Validation in San Jose, CA in a pharmaceutical company with novel drug delivery technology. The company recently had an IPO event and the stock has held very well and the technology holds promise to be a game changing improvement in the quality of care for many patients. The company has a world class team in place. Director of Validation is a hands-on role responsible for the execution of validation activities: To develop & implement harmonized validation processes & practices; Develop a qualified team; Manage validation/qualification of equipment, facilities, utilities, cleaning, sterilization, automated systems, and computer system validation in a cGMP environment. 

Skills & Experiences: 

Responsibilities: Ensure development & implementation of validation strategies & internal SOPs; Write & review qualification & validation documents; Lead & support qualification & validation of cGMP equipment, facilities, utility systems, cleaning & manufacturing processes; Develop & maintain risk based, quality driven procedures & practices; Lead risk assessment activities; Identify, hire & develop, manage & support company’s validation expertise; Support change control program with respect to facility, utilities, equipment, cleaning & computerized systems validation changes; Evaluate validation impact of manufacturing process changes & equipment upgrades; Complete activities related to regulatory filings, production schedules and/or customer needs with respect to facilities, utilities, equipment, computer system validation, etc.; Ensure Quality meets or improves on budget, cost & efficiency targets (KPI’s) in line with business objectives; Support QA activities related to the assigned projects, including, but not limited to: internal and external audits, deviations, change control and CAPAs; Other duties/activities may be necessary to support departmental or company goals. 

Skills & Experience: BS in life science or engineering; 10+ validation exp in bio/pharma industry; 5+ years of supervisory/managerial experience; Knowledge Good Engineering Practices, FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971) & validation such as GAMP 5, 21 CFR Part 11, and ASTM E2500; Knowledge of international & domestic cGMP regulations for pharmaceutical manufacturing; Technical writing, problem solving & analytical skills; Ability to review, analyze, summarize & interpret data, draw conclusions & make decisions/ recommendations; and Experience in project management. 

Quality Assurance – S. SJ

There is an immediate QA position available for support & performance of QA/QS functions/activities and adherence to applicable regulatory standards for medical devices. This is a vascular company founded by a seasoned entrepreneur whose previous company had $1B+ exit. This opportunity will offer competitive salary plus stock with huge potential.

Skills & Experience Required: BS in Science related area; 10+ yrs experience in FDA regulated industry; Exp with Quality Assurance practices & systems; Knowledge of ISO 13485 and FDA 21 CFR 820; MasterControl administration/process ownership; Maintain compliance of a certified QMS related to configuration control, document control, and change control. ASQ Certifications are a plus.

Responsibilities: Support devet & maintenance of QMS, ensuring alignment of corporate operations applicable regulations; Serve as system administrator for MasterControl Electronic Document Management and Training System (EDMS), including responsibility for configuration, user training, account management, training course creation and assignment & assessment of upgrades & patches. Maintain validated state of system throughout system lifecycle. Manage, process & track controlled documents from the Document Change Order (DCO) process until document approval or retirement, including updating related controlled documents; Revise controlled documents as appropriate & ensure timely reviews. Manage electronic approval of records/documents via DocuSign; Monitor & track completion of quality system records including CAPA, Deviation, and NCMR; Monitor training compliance & report any issues to management; Maintain Approved Supplier List (ASL) and ensure supplier files are current; Perform raw data review in support of technical reports and regulatory filings & Issue, track, and perform quarterly audits of laboratory notebooks. Assess corporate operations against quality system regulations, issue identification/ resolution including proper and timely documentation; Prepare quality metrics & reports; Facilitate & conduct internal & external audits; Perform history record review & disposition of device batches. Review/approve facility records as needed (pest control reports, cleaning logs, and environmental monitoring reports & Manage archival of hard-copy records.

Senior Manager CMC, Analytical Development – North San Jose, CA

There is an exciting job opportunity in San Jose, CA, to work on novel projects involving drug-device combinations for treating chronic diseases & participate in method and tech transfer from R&D to Manufacturing as appropriate. This is an exciting opportunity in a rapidly growing company to work with a world class team, on game changing technology with HUGE potential.

Requirements include: BS/MS in sciences PLUS 5+ years relevant bio/pharma experience; biologics analytical development exp in biophysical techniques & analytical characterization of peptides & proteins; solid oral dosage and/or parenteral sustained release formulation exp, exp in process development from early to late phase development; experience of working in GLP/GMP regulated environment, drug-device combination exp; knowledge analytical techniques such as various HPLC modes & detections, LC-MS, CE-SDS, peptide mapping, ELISA, cell-based assays, etc, for product characterization, comparability testing and PK/PD analyses; Exp in method validation and specification setting; Assessing chemical & physical stability of formulations, identifying stability, manufacturability, & performance critical quality attributes. Experience in protein purification & biologic formulation is a plus.

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.

JOBS – June, 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) 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.

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.

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.

JOBS – July, 2020

 

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

Senior Mechanical Engineering Technician – San Jose, CA

Requires 15+ years of experience.

Senior Electro-Mechanical Engineering Technician – San Jose, CA

Requires 15+ years of experience.

Senior & Junior Mechanical Engineer – San Jose, CA

The Senior Mechanical Engineer is responsible for evaluating and improving the company’s current drug delivery system while maintaining high quality and reliability standards. This will be achieved by testing the system and optimizing components or subassemblies as needed. In addition, he/she will be required to work with quality and regulatory to develop complete documentation for the device. The successful candidate will work independently and use sound judgment to deliver optimal solutions. This is a hands-on position that requires interaction and collaboration with a cross-functional team.

Responsibilities

• Evaluate the current design and identify opportunities to realize improvement in product consistency and increased throughput in a manufacturing environment
• Show proof of concept through prototyping and supporting test data, and coordinate implementation with appropriate stakeholders
• Take full ownership of documentation by following internal design control SOPs, leading verification/validation activities, and participating in phase reviews
• Create 3D models, engineering drawings and bill of materials
• Create comprehensive work instructions and manufacturing SOP’s
• Work with quality to resolve any issues with components or processes
• Establish working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
• Comply with company’s policies and guidelines regarding quality and regulatory

Qualifications

• Bachelor’s Degree in Mechanical Engineering
• Senior engineer requires 10-12 years experience and junior engineer requires 3-5 years hands-on experience in a design environment
• Experience with creating engineering drawings, BOMs, and product specifications
• In-depth experience with complex mechanical systems that interact with biology
• Prior experience in a medical device company
• Experience with design control process for medical devices and implementation of product in to manufacturing
• Working knowledge of FDA regulations and ISO, cGMP, QMS standards
• Good understanding of DFM and lean manufacturing
• Excellent verbal, written, presentation and interpersonal skills
• Strong analytical and problem-solving skills
• Knowledge and/or hands-on experience with machine shop tools
• Proficiency with SolidWorks required
• Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications

• Knowledge /experience with plastic injection molding
• Masters’ degree or higher in Mechanical Engineering or Biomedical Engineering

 

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 designing unique tests, developing fixtures, and analyzing the data. Additional duties may include reporting failures, and assisting in improving manufacturing processes to prevent prototype failures, support R&D with component design work, test fixture design, support verification testing, and interface with manufacturing to implement new design updates into the pilot manufacturing line.

 

Responsibilities

• Work with multi-disciplinary teams to define tests and perform verification testing
• Design and build appropriate test fixtures for completing the tests
• Assist engineering and bio team on evaluation of device failures and complete test reports to review improvements with the team
• Collaborate with manufacturing to create product assembly tooling, fixtures and work instructions
• Assist R&D and manufacturing in process development, including molding, bonding processes for parts, and component design
• Comply with company’s policies and guidelines regarding quality and regulatory

Qualifications

• BS in Mechanical Engineering
• 3-5 years of industry experience
• Must be hands on and adept at building and debugging fixtures
• Fluent with SolidWorks
• Excellent verbal, written, presentation and interpersonal skills
• Strong analytical and problem-solving skills
• Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications

• Prior experience in a medical device company desired

 

Cell Biologist with Islet Cell Experience – San Jose, CA

This is an opportunity to participate at grounds level with possibility of high potential outcome. Technology focuses on cure for diabetes and requires islet cell or related experience.

 

Leadership Opportunity – Milpitas, CA

There is a senior level leadership opportunity that requires prior experience with leading a neurological medical device company.

Leadership Opportunity – Union City, CA

A senior level leadership opportunity requires experience with taking a biotech company public.

JOBS: September, 2019

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

Clinical Trial Manager – San Jose, CA

Ideal experience: 8+ years experience in medical devices, ideally in neuromodulation.  Required, experience running clinical trials, and working with clinicians and medical centers.

Head of Regulatory – San Jose, CA 

Candidate must have 15+ years experience in bio/pharma industry. Experience working with biologics and taking a drug to market in the US and EU is essential.

Mechanical Engineer – San Jose, CA

The Mechanical Engineer is responsible for evaluating the current manufacturing processes and making design improvements to increase throughput, quality and reliability. This will be achieved by redesigning the current tooling and/or creating new tooling and equipment. The successful candidate will work independently and use sound judgment to deliver optimal manufacturing solutions. This is a hands-on position that requires interaction and collaboration with a cross-functional team.

Responsibilities

· Evaluate the current manufacturing processes /workflows and identify opportunities to realize improved product consistency and increased throughput
· Develop concepts and ideas for improving the exiting tooling as well as creating new tooling including semi-automation where applicable
· Take full ownership of tooling /fixture designs, conduct concept reviews, show proof of concept through prototyping coupled with supporting test data, coordinate with appropriate stakeholders for successful verification /validation, launch and documentation
· Create 3D models, engineering drawings and bills of materials
· Create comprehensive work instructions and manufacturing SOP’s
· Work closely with Process Engineering through the creation of verification /validation protocols (IQ,OQ,PQ) as well as successful execution, data generation, report and documentation
· Establish working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
· Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications
· Bachelor’s Degree in Mechanical, Manufacturing or related engineering fields
· 5-7 years hands-on experience in a manufacturing environment
· In-depth experience with complex mechanical /electromechanical design
· Extensive experience with precision mechanisms, pneumatics, fixtures /tooling and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
· Experience with creating engineering drawings, BOMs and product specifications
· Deep knowledge of material properties, heat treatment and surface finish
· Good understanding of DFM and lean manufacturing
· Excellent verbal, written, presentation and interpersonal skills
· Strong analytical and problem-solving skills
· Knowledge and/or hands-on experience with machine shop tools
· Deep knowledge of GD&T as well as proficiency with SolidWorks
· Prior experience with FDA regulations and ISO, cGMP, QMS standards
· Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications
· Knowledge /experience with electrical /electronics and PLC programming a big plus
· Knowledge /experience with plastic injection molding
· Experience with metal stamping, laser cutting and chemical etching
· Familiarity with cleaning and sterilization processes

Sr. Molding Engineer

Job Summary

The Sr. Molding Engineer is responsible for evaluating the current molding processes and leading the effort to increase throughput, quality and reliability. This will be achieved by redesigning the current tooling, creating new tooling /equipment as well as leveraging outside molding expertise. The successful candidate will become the resident expert in the areas of plastic injection molding and material selection. This is a hands-on position that requires interaction and collaboration with a cross-functional team.

Responsibilities

· Evaluate /characterize the current molding processes and identify areas of improvement while focusing on rapid manufacturing scale-up
· Work closely with the consumable engineering group and make recommendations for molding improvements such as use of alternate materials, parts consolidation, setup /process optimization etc. without compromising the design intent
· Conduct design concept reviews and present fresh ideas, new technologies and creative ways to take the current molding process to the next level
· Show proof of concept through rapid prototyping and supporting test data
· Take full ownership of all injection molding initiatives, coordinate with appropriate stakeholders from initial concepts through FAI, optimization, successful verification /validation, launch and documentation
· Work closely with Process Engineering through the creation of verification /validation protocols (IQ,OQ,PQ) as well as successful execution, data generation, report and documentation
· Develop /optimize molding parameters and establish best practices in molding methodologies
· Work with external companies as needed to outsource injection molding activities and manage the vendors through all phases of the projects including user requirements, RFQ, vendor selection, concept & design followed by verification /validation
· Create comprehensive work instructions and manufacturing SOP’s
· Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications
· Bachelor’s Degree in Mechanical, Manufacturing, Plastics or related engineering fields
· 7-10 years of extensive, hands-on experience with plastic injection molding including but not limited to mold design, capability studies and process characterization /optimization
· Experience with rapid prototyping and multi-cavity plastic injection molding
· In-depth knowledge of material science /plastics properties and metrology techniques
· Experience with creating engineering drawings, BOMs and product specifications
· Good understanding of DFM and lean manufacturing
· Excellent verbal, written, presentation and interpersonal skills
· Strong analytical and problem-solving skills
· Prior experience with FDA regulations and ISO, cGMP, QMS standards
· Knowledge and/or hands-on experience with machine shop tools
· Deep knowledge of GD&T as well as proficiency with SolidWorks
· Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications
· Knowledge /experience with micro molding
· Knowledge /experience with DOE, SPC, FMEA
· Experience with metal stamping, laser cutting and chemical etching
· Familiarity with cleaning and sterilization processes

JOBS: April, 2019

Please see some of my current opportunities below. All opportunities are for local candidates with valid work visa and require deep industry experience.  If you have an interest then please send an email (resume as an attachment) at wd underscore darshana at hot mail dot com.

Director of Pilot Manufacturing – San Jose, CA

Innovative medical device company located in San Jose, CA has an immediate opening for Director of Pilot Manufacturing.  This position will report to VP of Manufacturing Operations. This low volume production line is crucial to the company’s several ongoing preclinical studies.

Duties and Responsibilities
Lead day to day operations including injection molding, aseptic processing, capsule assembly, supply chain and other related activities; Develop detailed production planning, resource allocation, equipment maintenance, operator training etc.; work closely with product development, pre-clinical & clinical groups and quality in order to ensure achievement of targets & develop manufacturing plans & detailed production schedules; Manage inventory of raw materials & injection molded components; Manage human resources in pilot manufacturing; Maintain a strong commitment to quality; Comply with U.S. Food and Drug Administration (FDA) cGMP regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Requirements
Strong problem solving & analytical skills; Experience with use of statistical analysis & design of experiments for product optimization and validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation; Experience working with ERP systems & Broad GMP manufacturing background with Class III medical devices. Requires BS/MS in Mechanical, Electrical or Industrial Engineering and 15+ years’ experience managing & supervising manufacturing with a strong history of hands-on experience successfully transferring new products into manufacturing & Deep technical experience with manufacturing processes, design control and quality systems. Also required, strong problem solving and analytical skills; Experience with use of statistical analysis and design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test and test implementation; Experience working with ERP systems. Also essential is proven ability to coach & develop employees & develop effective cross functional relationships. This position requires interface throughout all levels & functions of the organization.

Director of Manufacturing Automation – San Jose, CA

This position requires a dynamic, energetic, self-driven, engineering leader with broad manufacturing engineering and automation experience & will report to VP of Manufacturing Operations. The Director of Manufacturing Automation will lead the development of fully automated manufacturing systems for all aspects of company’s disposable drug tablet manufacturing. This individual will be responsible for defining system requirements, developing proof of principle systems, developing timelines and managing budgets and providing direct oversight and management of automation suppliers as well as driving the implementation and validation of manufacturing lines. This individual will work closely with product development, manufacturing engineering and quality in order to ensure manufacturability, achievement of targets, and develop processes for optimum manufacturability.

Responsibilities: Define functional & detailed requirements & specifications for manu automation, including quality & regulatory requirements; Manage internal & external process automation programs, project schedules & budgets; Develop facility plans & specifications for manufacturing scale-up; Oversee installation & qualification of automated manu systems; Comply with USFDA cGMP regulations, (ISO), Company policies, operating procedures, processes & task assignments.

Requirements: Experience managing and leading complex cross functional projects involving, electrical, mechanical, quality aspects; Experience with mechatronics or automation engineering including machine, mechanism and fixture design; Strong problem solving and analytical skills; experience with use of statistical analysis & design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation. This position requires interface throughout all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome.  BS/MS in Mechanical, Electrical or Industrial Engineering & 15+ years’ experience managing an engineering group responsible for medical device development and manufacturing engineering with a strong history of hands-on experience is required. Also required Deep expertise in manufacturing automation for large scale manufacturing

 

JOBS: August, 2018

Please see some of my current opportunities below. All opportunities are for local candidates with valid work visa and most require deep industry experience. Contract opportunities are posted at the bottom. If you have an interest then please send an email (resume as an attachment) at wd_darshana at hot mail dot com.  Please bookmark and keep checking here for updates on new opportunities.

Director of Assay Development – Palo Alto, CA

There is an exciting opportunity for Director of Assay Development in a VC backed startup based in Palo Alto, CA. Company is developing unique diagnostic platform to quantify salivary biomarkers for variety of diseases & physiological conditions. Candidate will work closely with electrical engineers to transform an oligonucleotide-based assay from optical measurements to electrical measurements on company’s proprietary platform & will play a key role in development of a high throughput assay for clinical R&D studies.

Qualifications: Experience in Molecular Biology, Biochemistry or related field w/ method development focus; data analysis & management skills; knowledge of oligonucleotide-based assay & application on biosensor based Field-Effect Transistor (Bio-FET) for developing in-vitro diagnostic device; Expertise in assay devt & validation methods, in design & prosecution of in vitro bio-recognition -based assays, and 3-5 years of hands-on exp in biomarker quantification using a variety of biophysical techniques.  Aptamer-related experience is advantageous.

Responsibilities: Manage team of lab researchers; Assist with data prep for analysis & reporting; Maintain lab equipment functionality; Track inventory, lab records, good lab practice (GLP) and safety; & Troubleshoot; Adapt assays to multiple platforms & optimize biosensing measurements; Validate biochemical assays & biomarker quantification; Develop & set-up biochemical & in vitro assay for high throughput platforms; Train team members; Provide technical information, experimental assay design & data analysis to team members.

Senior Scientist of Assay Application – Palo Alto, CA

There is an exciting opportunity for Senior Scientist of Assay Application, in a VC backed startup based in Palo Alto, CA. Company is developing unique diagnostic platform to quantify salivary biomarkers for variety of diseases & physiological conditions.

Qualifications: Experience in Molecular Biology, Biochemistry or related field w/ method development focus; data analysis skills; experience in protein and nucleic acid work using binding assays molecular interaction analysis (e.g. ELISA, SPR, FRET), protein microarray and surface chemistry. Aptamer-related experience is advantageous.  

Responsibilities: Assist w/ data preparation for analysis & reporting; Manage lab – inventory, records, equipment functions &  safety; Troubleshoot bench work; Assay Development, design & analysis; Work multidisciplinary team to design, develop & optimize assays & devices (optical and electrical); Adapt assays to multiple platforms & optimize biosensing measurements.; Validate biochemical assays for biomarker quantification; Facilitate technical communications between engineer and assay development teams.

Mechanical Engineer – Santa Cruz, CA

Company focusing on an array of brain computer interface devices to address a range of neurological problems has an opening for Mechanical engineer.

Head of Manufacturing Engineering – San Jose, CA

There is an exciting opportunity for Head of Manufacturing Engineering in San Jose, CA.  This is an exciting opportunity with high potential.

Responsibilities include,  implementing pilot manufacturing line, develop components & assembly manufacturing processes including materials science and selection, develop processes for injection molding, conventional & novel polymers, micro-product molding, converting &  sealing plastic films, micro-tablet compression, clean room processing & large molecule processing.

Required: BS in Engineering plus 12+ years of mechanical engineering experience in medical device industry. Any of the following, highly desired: Experience in consumer product medical device, pharmaceutical (transdermal and solid dosage), and combination product design, manufacturing process development, manufacturing equipment design and development, pharmaceutical and sterile device packaging development, 3-D metal and plastic product design, tooling design and fabrication, injection mold design and fabrication, CNC and g-code programming, production engineering management, maintenance management, manufacturing management, and project management and experience in new product launches through heritage product manufacturing.

Software Engineer – Santa Cruz, CA

Company focusing on an array of brain computer interface devices to address a range of neurological problems has an opening for SW engineer.  Embedded microprocessor experience and windows app experience is required. Highly preferred, design/coding experience for embedded systems with wearable/motor-driven devices.

CFO – San Jose, CA

There is an exciting opportunity for CFO for a company, in San Jose – CA. Found by a veteran leader the company focuses on disruptive drug delivery platform technology. 15+ years M&A and licensing deals experience in bio/pharma industry is required.

Director of Program/ Project Management – Santa Cruz, CA

There is an exciting opportunity for Director of Program/ Project Management for a company located in Santa Cruz – CA. This company is found by a veteran leader and focuses on an array of brain computer interface devices to address a range of neurological problems. Candidate is required to have 4+ years of medical device program or project management experience in electromechanical systems area.

Head of Regulatory – San Jose, CA

There is an exciting opportunity for Head of Regulatory for a company, in San Jose – CA. Candidate must have 15+ years experience in bio/pharma industry. Experience working with biologics and taking a drug to market in the US and EU is essential.

Design QA Scientist –  Pleasanton, CA.

Responsibilities: Support DQA Principal Scientists and Project teams; Review & approve documentation consistent with design control regulations; technical verification, risk; Assist DQA project team to assess completion of milestone deliverables; Assist in the review and development of high SOPs; Support audits/inspections; Other duties as requested.
Requirements: Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline, or equivalent combination of education and work-related experience.
Preferred: Job-related Professional License(s) or Certification(s) and 5 Years Development, Manufacturing and/or Quality Assurance experience under established quality regulations.

Clinical Research Associate II – California 

Responsibilities include, participate in design, planning, implementation and overall direction of clinical research projects; ensure compliance with the overall scientific study objectives;  work with international investigators and key customers as well; Travel to field sites to monitor studies; Receive general instructions; plans and prepare studies; Review study protocols, report manuscripts; Contribute technical & clinical operations expertise for these documents; Work with Data Management & Biostatistics staff on the design of documents and processes for the collection of study data from participating sites; Collect & maintain legal and regulatory documentation, as applicable; Assume responsibility for training & coordinating certification of study site personnel; Ensure accurate and complete study management/data collection and transfer to data management; Ensure site compliance with regulations and study protocol; Monitor the sites and provide technical assistance, as necessary; Assist, prepare and manages study timelines; Manage material logistics for the studies; Conduct reference material testing in-house. Organize investigator meetings, as necessary; Participate in Project Team Meetings; Keep informed of trends and developments in clinical research; Know &  effectively use the broad concepts of a particular field or speicalization to resolve problems of limited scope and complexity; Analyze alternative approaches to solve problems or devleop new perspectives & existing solutions. Bachelors degree in a scientific discipline or related field, or equivalent combination of education and work experience is required. Certificate of completion of sections 1 through 6 is required. Minimum 2-6 years of relevant clinical research experience and knowledge of regulations and guidelines is required.

Clerk – San Jose/ Santa Clara, CA

There is an opportunity for a Clerk in a biomed company, located in San Jose/ Santa Clara, CA area.

Responsibilities: Follow standard operating procedures to enter orders for high complexity clinical lab tests; Be responsible for efficient and accurate entry of customer and patient demographic data, clinical information, test request information and physician information; Review, understanding, and executing customer-specific requirements for order entry; Create service requests in CRM system to document issues and work closely with client service team to resolve and escalate incomplete or unclear order issues; Check work of others to ensure order entry quality; Troubleshoot problems & assist employees with process questions; Fax requests to customers to resolve unclear orders; Run queue reports to ensure daily tasks are completed; Assist account set up administration; Act as training resource for department employees; execute process improvement recommendations; Retrieve forms from lab; Escalate issues to appropriate internal resources; Interact with Finance team to provide patient billing information in a secure manner.

Skills: 2+ years experience working in the clinical laboratory, medical, order management, or related field; Experience using Customer Relationship Management (CRM) Software (e.g. NetSuite, Salesforce.com), laboratory information systems. Microsoft Office Suite a plus. Must be able to follow laboratory procedures and must adhere to the laboratory quality control policies; Ability to identify & act on issues within an order that may impact customer satisfaction & test turnaround time; Must be able to type 45 words per minute with excellent accuracy; Must be able to lift up to 35 lbs.

 

Regards, Darshana

4088980000

 

CONTRACT OPPORTUNITIES 

RMD Biospecimen Scientist – Pleasanton, CA — 6 mo. contract

The BioSpecimen Management (BSM) Scientist position will facilitate the daily operations associated with providing the best-in-class simple biological solutions to customers. Biospecimen solutions include acquisition, characterization, and management of biological materials, and build of select panels fit for purpose for RMD research. Responsibilities include deliver simple, efficient solutions, facilitate receipt of shipments of human biological samples, verify sample integrity and data accuracy, process (centrifuge, aliquot, and pool) samples, consolidate inventory, retrieve and distribute samples, maintain inventory of supplies and ships supplies and facilitate routine activities in the build of custom panels, in close communication with team members. Also includes, responsibility for the accuracy, quality, and timeliness of all assigned projects, tasks and related activities,  accontablity for electronic records management, use of validated systems, and keep supervisor informed of project status.  Requires, Associate degree or certification in Biological Science or related field, or equivalent combination of education & experience, experience handling biological samples, understanding of good laboratory, data and documentation practices, and experience with basic computer application.

Scientist 1 – Pleasanton, CA: 6+ Months Contract

This opportunity is with NGS workflow controls for the RSS assay development team that identifies and tests cutting edge reagents, technologies or protocols that are supporting the development of products in Oncology, Genetics, Infectious Disease and Automation/Sample Preparation. Areas of interest include short and long read sequencing technologies, low input and difficult sample preparation methods and creating integrated workflows. Candidates must be able to work in a collaborative, exciting, and fast-paced team environment.
Responsibilities: Operate & maintain equipment, interact with LIMS databases, complete projects in a timely fashion, research & development, and give presentations at weekly meetings. Additional responsibilities: Operation of different genomics analysis technologies such as next-gen sequencing, microarrays, real time PCR and ancillary equipment for quality control and validation; Develop, validate & apply methods for various genomics methods mainly focused on sequencing; Process include nucleic acid isolation and quantification, PCR amplification, library preparation, plate normalizations and Work with senior personnel, perform early development activity to create new workflows that are robust, cost-effective and time efficient; Collaborate with R&D to transfer new assays and methods to automation platforms; Work closely with IT group and instrument vendors to develop and implement automated workflows; Accurately and consistently record experimental methods, materials & results in electronic laboratory notebooks; Analyze data, evaluates results, form conclusions, and determine future experiments; Present findings or comprehensive project status reviews at internal/external seminars/meetings; Apply advanced technical writing & graphical skills to produce reports & documents; Prepare summaries, reports, presentations, manuscripts, etc.; Present early development work including scientific background information & project updates at internal staff meetings and at cross-functional team meetings; Determine all chemicals, reagents & supplies needed for a project; develop a strong knowledge of all related third-party vendors and their technologies and products; Establish and maintain productive relationship with personnel in development; orient & trains new Research Technicians & peers.
Requirements:  Strong Molecular Biology background or Biochemistry or Immunology background with strong knowledge of Molecular Biology;  Experience performing next-generation sequencing methods (Exome, whole genome, RNA sequencing) a plus; Bachelor of Science with a minimum of 2 years of lab experience.

Tale of two Americas influencing #Election2016 & Open Letter to Hillary Campaign

Here’s something to think about… the country is soooo divided that Americans are living two distinctively different realities; it is almost like they are living in two different nations.

America 1

Imagine that you live in the Appalachian mountains off of Virginia or Ohio.  Jobs in mining and manufacturing that were once plentiful are gone and no one has offered you re-training to operate in a different reality that has been emerging.  Opioids & alcohol are easily available to dull your pain (in fact, in parts of Ohio, first time more people are dying from opioid addiction than natural causes).  You see yourself as having no future; the best is behind you. You are enormously proud of your heritage, hard work ethic, and your religious values.

Church used to be your anchor but now church attendance has fallen; you have no anchor. You just want someone new at helm in this country, to shake things up – you don’t care how or who it is as long as the person talks to you in a language you understand and holds someone; an outsider responsible for your plight. Your current reality is so painful that you believe you once lived in a phenomenal nation, and you are losing it to outsiders who steal your jobs. Perhaps you don’t see many immigrants where you live, but you hear statistics of jobs being offshored, terrorists rarely target your geographical areas and you don’t often see women in hijabs but you hear about terror attacks when they happen and it scares the s*&^ out of you. Lowering or raising federal minimum wage has no impact here because there is no economy, no jobs. If someone tells you they will build a wall to keep immigrants out then it resonates with you.  If someone promises to bring back outdated mining jobs back, you are filled with hope.

America 2

Now imagine  you are living in a place like Silicon Valley in California, a place on the cutting edge of innovation.  There is a different social and economic reality.  You work with Muslim engineer, Chinese American scientist, Mexican American patent attorney, Iranian American realtor and your child’s teacher is lesbian.  These people are not aliens but your next door neighbors and share similar interests and values, as you.  Price for 2 BR condo in newly built (and fraught with problems), millennium towers in San Francisco costs around $2M and when economy tanked in 2009 (right after George Bush left office), California was hit harder than Ohio and Indiana.  The number of people filing for bankruptcy protection in the first quarter of 2010 ranked California at number one for bankruptcy protection. Right after Florida and Nevada, California also had one of the highest foreclosure rates with 1 in every 192 houses being foreclosed.

I can personally vouch to the impact of extremely high unemployment, while living in a state where everything is more expensive.  Both my businesses died.  I offered recruitment and soft skills training, but no one was hiring and no one had budget for soft skills training.  In 2009, I made less than $10,000.  I sold my house and while my business continued to remain in a nearly dead mode, in 2010 and 2011, I pounded the pavement for hourly jobs at Starbucks etc. for which I was always considered overqualified.  But California is back in business and so am I; better than ever before.

How did California do it?  I think California did it by leveraging the global trends and with a unique blend of cutthroat captialistic competition and compassionate socialism.  Corporations may not be people but both companies and people in CA exhibit this blend of competition and compassion.  I have some more thoughts on this and if I am not distracted by other things, I may study this more and write another blog.  But for this post, I want to focus on what is required of a political leader to bring the two Americas together. 

Open letter to Clinton Campaign

Henceforth, Ms. Clinton must maintain a laser sharp focus on issues that matter in the swing states.  All focus should be solely on large percentage of undecided voters who swing back and forth between Trump and Hillary.  Stop talking about how racist Trump is or that he is adhering to Alt-Right.   More people learn how racist he is, more votes it is getting him. Trump’s entire candidacy is based on inciting hate and division and taking his message to the masses is only enabling him.  Besides, he has so much air time, everything he does and says is covered.

While American women would largely care for issues like equal pay for equal work, do not focus on sexism in Trump campaign.  In California, I saw ads targeting women, with mention of Trump’s abominable remarks denigrating women.  But California is tuned in already,  In the swing states, there are likely to be more women in committed relationships and more than right to choose and equal pay, they care more for jobs for their husbands.  Still for many, it is a man’s serious and primary responsibility to earn a living.

Do not mention immigration.  Trump has made entire immigration dialog in the country about sound bites (big wall, beautiful wall, Mexico will pay for it, deporting etc.) and more confident and more racist his sound bites, more they are striking a chord.  He effectively created an environment of fear where soundbite solutions are very appealing.  I don’t believe Ms. Clinton can give any effective soundbites on immigration.  That is simply not her style and people are not in the mood to listen to logic on this issue.

Do not mention environmental issues.  While this has been President Obama’s crowning achievement, it does not figure in top 10 priorities when you put it on Maslow’s hierarchy of needs.  Americans are generally more present oriented but are certainly focusing squarely on short term and immediate benefits during this election season.  The more Trump talks about how things will change on November 8, less concerned people are about benefits to future generations.  

Also, do not focus in the debate on Trump’s lack of foreign policy experience.  Americans often care little about foreign relations.  President GHW Bush made great strides in foreign relations and he got little credit for it.  Besides Trump scored a victory looking Presidential in Mexico.  More than that, no one cares.

Think of Maslow’s hierarchy of needs that goes from fulfillment of basic needs and only after they are satisfied, it progresses to focus on social needs.  When people’s basic needs of healthy food, clean water, and safety are not satisfied, focusing on social issues like women’s rights, race relations, immigration, pay equality, and equal rights for LGBTQ, are a luxury they can’t afford.  While Trump may be trigger happy to get access to the nuke button, for America 1, it does not feel like a looming disaster; instead, it enhances their feeling of safety.

Here are the issues that Clinton campaign should singularly focus on.  

Focus on JOBS

Forget all incredible and horrific things said and done by Trump that make him unfit to be the President. Stay singularly focused on jobs and the economy and his lack of concrete plan to create jobs.  In his post convention interview with George Stephanopoulos, Trump was questioned about jobs.  See clip below at 11 minutes, where Trump when asked why he brings in people from overseas to work at Mara Lago resort in Florida, he tried to duck the question by taking talking about other companies offshoring jobs and Stephanopoulos keeps bringing the discussion back to his issuing almost 500 offshore visas since 2010 and Trump deflects it again saying everyone does it because they can’t find American workers.  Hummm, they can’t be re-trained for low level jobs then how is he going to pressure Samsung and Apple to bring skilled jobs outsourced to Indian and Chinese engineers at fraction of the cost, back to America?  Use this clip with Clinton’s concrete plan to continue to create job growth in America.  This is not a sensational piece of news that elite media (largely favored by America 2) will play over and over but you must capitalize on.

http://abcnews.go.com/ThisWeek/video/donald-trump-41028199

Respect & concrete benefits to America’s Veterans

America owes to our veterans.  But that sincerity must be expressed with something more tangible than “America loves you and is deeply grateful to you for your service”.  If one vet feels strongly enough to give away his purple heart to Trump then that is one too many vets disillusioned, and whom we must re-engage with.  Our vets must have certain level of job security, access to constant retraining, access to healthcare, including easy access to mental healthcare.  There must be early intervention before PTSD takes an enormous toll on their lives and the lives of their loved ones.  Talk about how Obamacare has enabled easier access to healthcare for so many people.

Access to mental healthcare and PTSD treatment

Trauma has become a significant part of modern life.  It is not only our vets who need access to treatment for PTSD, but also foster care children who are often shuttled around from family to family, from one location to another.  Children who witness domestic violence, often suffer from PTSD, while their needs may be completely ignored at home and outside.

Concrete plan to deal with opioids and other drugs

 As mentioned above, in parts of Ohio, first time more people are dying from opioid addiction than natural causes.  Obama administration and FDA has been deeply concerned about escalating use of opioids and other drugs but how frequently do we hear from Hillary campaign about the plan that is in process?  For instance, the Obama administration is making it easier for doctors and law enforcement to use anti-addiction drugs.  FDA is putting in place steps so that companies seeking approval of any new opioids, must include abuse-deterrent properties and appropriate labeling. But more importantly, there are concrete steps in place to deal with current trends of opioid abuse, including additional training to prescribers on pain management and safe prescribing, encouragement for abuse deterrent formulations, make naloxone more easily available to treat opioid overdose, and encouraging new class of pain medicines without the same risks as opioids.  Ms. Clinton must relentlessly address opioid abuse and significant strides being made under Obama administration to counter that.  

Finally, I humbly suggest that Hillary campaign and the media stop playing over and over and over Trump soundbites that show his racial, gender and other biases – contrary to people being turned off by such bigotry, in the climate of fear he has created and the foundation of hate he has laid, his bigotry gives people a feeling of safety and hope. Considered dialog detailing the history of events and people as done by Rachel Maddow and others and late night shows (Colbert, Noah, Bee, Oliver and others) that point out ridiculous aspects of Trump messages with humor, are however excellent.

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.