Archive for category JOB OPENINGS

JOBS – November, 2018


Flat vector illustration, job search, recruitment, workgroup, freelance, web graphic designPlease 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.

Senior Manufacturing Engineer – San Jose, CA

There is an exciting opportunity for senior mechanical engineer with 12+ years experience in broad range automation, design process and improve manufacturing efficiency, in a company located in San Jose, CA

Senior Quality Engineer – San Jose, CA

There is exciting opportunity for Senior Quality Engineer with 10+ years experience in class 3 medical device company, in San Jose, CA.

Senior Mechanical Engineer – San Jose, CA

There is an exciting opportunity for senior mechanical engineer with class 3 device experience, for a company located in San Jose, CA

Head of Clinical – San Jose, CA

There is an exciting opportunity for head of clinical (actual hiring will happen in 2nd quarter in 2019).

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.

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.

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.

 

Contract signed and sealed, pen, stamp, documents for signature, document folder iconCONTRACT 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.

Leave a comment

JOBS: August, 2018


Jobs search concept, Big red text word "Jobs" on white paper and Magnifying glass for jobs searchPlease 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 signed and sealed, pen, stamp, documents for signature, document folder iconCONTRACT 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.

, , , , , , , , , , , , , , , , , , , , , , , , , , ,

Leave a comment

JOBS: May, 2018


The word Jobs in cut out magazine letters pinned to a cork notice board

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.

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.

 

Contract signed and sealed, pen, stamp, documents for signature, document folder iconCONTRACT 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.

Leave a comment

JOBS: April, 2018


It's Time For A New Job, Business ConceptPlease see some of my current opportunities below. All opportunities are for local candidates with valid work visa and most require deep industry experience. 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.

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.

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. 

 

 

Leave a comment

JOBS – February, 2018


Image result for jobsPlease see some of my current opportunities below. All opportunities are for local candidates with valid work visa and most require deep industry experience. If you have an interest then please send an email (resume as an attachment) at wd_darshana at hot mail dot com.  I am expecting many opportunities and I will update more details and other opportunities as they become available. Please bookmark and keep checking here during the busy month of February.

Senior Validation Engineer – San Jose, CA

There is an exciting opportunity for Senior Validation Engineer for a company located in San Jose – CA. This company found by a veteran leader focuses on disruptive drug delivery platform technology. Requirements include: BS in Engineering, Exceptional overall knowledge of validation cycle; Experience performing SOPs, IQ, OQ and PQ’s of plant processes & equipment; and Clean Room experience. Isolator validation experience is highly desirable.  

Responsibilities: Help multidisciplinary team optimize design of key system components; interface with suppliers and manufacturing to implement new design updates into pilot manufacturing line; lead solutions to challenging design problems in a timely manner; initiate and execute validation studies; interact with management & staff to manage and facilitate the validation process; pan, schedule & organize validation projects for new & existing areas, including manufacturing processes, plant systems, cleaning & equipment; prepare project plans; identify projects & problems requiring validation support; plan & assign priorities to ensure critical projects meet required deadlines; develop & implement design IQ/OQ/PQ and validation campaigns, write protocols for process validation, cleaning, IQ/OQ and performance qualification; coordinate validation and IQ/OQ/PQ activities with Manufacturing, Quality and outside contractors providing leadership, training, and guidance; monitor & support the execution of protocols through training, facilitating & problem-solving; review & analyze moderately complex analytical & physical data generated from validation activities; write validation final reports; recommend validation strategies, priorities & resources; ensure accuracy & integrity of protocols, reports & documentation generated to meet regulatory authorities; ensure critical deadlines are met for complex projects; participate in design FMEA’s & plan steps for mitigating risks; perform component verification testing & product validation testing; collaborate with manufacturing to create product assembly tooling, fixtures & instructions; povide engineering support to manufacturing by trouble shooting process and component problems on the pilot manufacturing line.

Senior Mechanical Engineer – Milpitas, CA

There is an immediate opening for a candidate with exceptional mechanical design and analytical skills to conceptualize, develop and verify novel medical device prototypes with emphasis on optimizing the efficiency and reliability of the device to a very high degree. Responsibilities include, work with multi-disciplinary teams to optimize design of key system components, iterate design quickly,  develop subassemblies, safety requirements, reliability and product specs from prototype with input from regulatory & marketing, interface with suppliers and manufacturing to implement new design updates into the pilot manufacturing line, design for high volume disposable device, participate in design FMEA’s & plan steps for mitigating risks, perform component verification testing & product validation testing, and collaborate with manufacturing to create product assembly tooling, fixtures and instructions. Requirements include, 7+ years of industry experience, familiarity with SolidWorks or CAD software, ability to develop unique mechanical tests to optimize prototype, and fluent understanding of solid mechanics or mechanical design.  Familiarity with molding processes and designing plastic parts and process development work such as bonding plastic parts or dip coating, big plus.

Senior Scientist/ Associate Director – PK – Biologics — San Jose, CA

Senior scientist/ associate director of PK, biologics is an exciting opportunity to work on novel projects involving drug-device combinations for treating chronic diseases. Requirements include, PhD in pharmacokinetics, drug metabolism or related, 10+ years industry exp in development of biologics, deep grounding in scientific principles of PK, PD & immunogenicity, ability to lead bioanalytical & PK and safety studies, deep knowledge of PK & drug metabolism principles & regulatory guidance, and prior experience with multiple INDs. BLA experience, a huge plus.  

Responsibilities include:   Lead the PK team to execute all preclinical and clinical PK studies,  oversee in house or outsourced PK data, oversee preclinical & clinical PK aspects of biosimilar programs, create custom study designs & protocols and implement them to evaluate new innovative, drug-device combination products, interface with ADME and PK experts, contribute to hands-on laboratory work and troubleshoot as needed which may include isolated tissue, cell-based, colorimetric, HPLC &  ELISA assays, support filing of applications for human studies by preparing reports &  appropriate sections of regulatory documents and represent the company at EMA/FDA meetings,analytical validation, build & maintain CRO relationships, lead development sub-teams with accountabilities for overall assay, product development and validation plans, assay development from investigation through validation and transfer in line with budget and timeline.

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.

Research Scientist – San Jose, CA

This is an exciting opportunity for a bioanalytical scientist to join a multidisciplinary team to work on a drug delivery combination device.  Requirements include, background in biochemical analysis such as spectrophotometric, fluorescence immuno assays, HPLC, CE, LC-MS. Experience with microplate assays and experience with Luminex MapX technology and experience in liquid handling robotic platforms for bioanalytical assay workflows is big pluses.  Qualifications include M.S. or Ph.D in biochemistry, chemistry, engineering or related discipline, hands-on experience (at least 2 years) in bioassays and liquid handling in a pharmaceutical or biotechnology research lab, and proficiency in both writing and optimizing scripts on automated liquid handling platforms (e.g., Beckman, Hamilton, Tecan etc.,).

Senior Validation Engineer – San Jose, CA

Company developing a novel drug delivery platform technology has an immediate opening for Senior Validation Engineer with exceptional overall knowledge of the validation cycle.  The candidate must have vast experience performing IQ, OQ and PQ’s of equipment.  Clean Room experience is a must and Isolator validation experience is highly desirable.  Responsibilities include: optimize the design of key system components; initiate & execute validation studies throughout the facility; plan, schedule & organize validation projects for new & existing areas; prepare project plans; interface with suppliers and manufacturing to implement new design updates in to the pilot manufacturing line; plan & assign priorities to ensure critical projects meet required deadlines; recommend validation strategies, priorities & resources; write validation reports; ensure accuracy & integrity of protocols, reports & documentation; lead solutions to challenging design problems in a timely manner; collaborate with manufacturing to create product assembly tooling, fixtures and instructions.

Production Supervisor – San Jose, CA

A company developing a novel drug delivery technology platform has an opening for a production supervisor who will be responsible to manage the Manufacturing Department associates that currently manufacture the device.  The Supervisor will be in charge of the training of all the associates, ensure Safety training and compliance is achieved in a daily basis, manage the weekly production schedule, hold daily production meetings with associates, report equipment malfunctions to manufacturing engineering group and follow up, schedule equipment maintenance and calibration, organize manufacturing areas (5S), control gowning materials used in the areas, and maintain safe environment, good documentation practices, monitor attendance and compliance with applicable FDA and ISO requirements. Must have familiarity with all manufacturing equipment, ability to read blue prints, assembly drawings and BOM’s (Bill of Materials), experienced in writing, reviewing standard operational procedures (SOP’s), familiarity with tools, instrumentation and calibration equipment, ability to manage schedules, conserve resources and supplies to facilitate minimum waste and ability to supervise and manage additional operators.  BA/BS plus 5+ years’ experience in general manufacturing environment with the strong background in supervision of 10+ associates is required. Ability to commit to flexible schedule and prompt arrival for shifts , experience with procedure generation and with classified room environments is essential.

 

 

Leave a comment

JOBS: November, 2017


Image result for jobsPlease see opportunities below. All opportunities are for local candidates with valid work visa. If you have an interest then please send an email (resume as an attachment) at wd_darshana at hot mail dot com.  As more details will become available for opportunities, I will update and post them here.

Senior Mechanical Engineer with Exceptional Design & Analytical Skills: San Jose, CA

There is an exciting opportunity in San Jose, CA for senior mechanical engineer to work in the design of a smart drug delivery pill with an aim to optimize the efficiency and reliability of the device, working in a multi-disciplinary team environment. This is uniquely exciting opportunity with serious potential.

Responsibilities: develop subassemblies with considerations for mechanical performance, safety requirements, and reliability for a drug delivering device; Develop product requirement specs from testing and development of prototypes and input from regulatory and marketing; Iterate design quickly; Design for high volume disposable device; Participate in design FMEA’s and plan steps for mitigating risks; Perform component verification testing and product validation testing; Collaborate with manufacturing to create product assembly tooling, fixtures and instructions; Provide engineering support to manufacturing by trouble shooting process and component problems on the pilot manufacturing line; Responsible for selecting and managing vendors

Familiarity with SolidWorks or other CAD software, ability to develop unique mechanical tests to optimize prototype, fluent understanding of solid mechanical design required. MS in Mechanical Engineering plus 7 years of industry experience preferred. Familiarity with molding processes and designing plastic parts and process development work such as bonding plastic parts or dip coating, a huge plus. 

Mechatronics Engineer – Santa Cruz, CA (requires 2+ years of experience) offers exciting opportunity to work with a veteran leader in a disruptive neuromodulation technology.

Senior Mechanical Engineer – Milpitas, CA (requires 15+ years of class 3 medical device experience)

Junior Mechanical Engineer – Milpitas, CA   (requires 4+ years of medical device experience)

Manufacturing Engineer – San Jose, CA (with 5+ years experience in machine design, fixtures & fabrication)

Technician – San Jose, CA (with 5+ years experience in fabricating fixtures & bench testing experience)

Assembler (with 5+ years experience in mechanical assembly skills)

ME Technician – San Jose, CA (requires 5+ years experience)

Battery Manufacturing Engineer – Milpitas, CA (requires Chemical Engineering background plus experience in process development.

Reliability Engineer – San Jose, CA

Senior Biochemist – San Jose, CA

Pharmacokinetist – San Jose, CA

Marketing Director – Santa Cruz, CA – To help establish commercialization and reimbursement strategy for exciting neuromodulation technology.

Clinical Director – Milpitas, CA

Lab Director  – Milpitas, CA

Regulatory Director – Milpitas, CA

Leave a comment

JOBS – October, 2017


Image result for jobsAll below opportunities are in the US and require valid US work visa and prior experience in biomedical industry.  If interested in any opportunities below, please send me an email (resume as an attachment) and include position title in the subject line.  You can also find me on LinkedIn. (Or send me a message with title of the position that interests you, how it matches your background & your contact info). Emails with proper subject line, some details in the body of the email to my hot mail address or linkedin will get quicker response.
PS: If you are looking for outstanding contract engineering expertise with mechanical and electro- mechanical systems for medical devices including small scale manufacturing expertise for regulatory submissions etc., then let me know and I will be happy to connect you with couple of companies in the bay area, CA.

Mechatronics Engineer – Santa Cruz, CA (requires 2+ years of experience) offers exciting opportunity to work with a veteran leader in a disruptive neuromodulation technology.

Senior Mechanical Engineer – Milpitas, CA (requires 15+ years of class 3 medical device experience)

Junior Mechanical Engineer – Milpitas, CA   (requires 4+ years of medical device experience)

Manufacturing Engineer – San Jose, CA (with 5+ years experience in machine design, fixtures & fabrication)

Technician – San Jose, CA (with 5+ years experience in fabricating fixtures & bench testing experience)

Assembler (with 5+ years experience in mechanical assembly skills)

ME Technician – San Jose, CA (requires 5+ years experience)

Battery Manufacturing Engineer – Milpitas, CA (requires Chemical Engineering background plus experience in process development.

Reliability Engineer – San Jose, CA

Senior Biochemist – San Jose, CA

Pharmacokinetist – San Jose, CA

Marketing Director – Santa Cruz, CA – To help establish commercialization and reimbursement strategy for exciting neuromodulation technology.

Clinical Director – Milpitas, CA

Lab Director  – Milpitas, CA

Regulatory Director – Milpitas, CA

 

 

Leave a comment

JOBS – July, 2017


Image result for JobsAll US based opportunities require valid US work visa and prior experience in biomedical industry.  If interested in any opportunities below, please send me an email (resume as an attachment) and include position title in the subject line.  You can also find me on LinkedIn. (Or send me a message with title of the position that interests you, how it matches your background & your contact info). 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. Emails with proper subject line, some details in the body of the email to my hot mail address or linkedin will get quicker response.
PS: If you are looking for outstanding contract engineering expertise with mechanical and electro- mechanical systems for medical devices including small scale manufacturing expertise for regulatory submissions etc., then let me know and I will be happy to connect you with couple of companies in the bay area, CA.

Test/ Quality Engineer – Santa Cruz, CA
There is an exciting opportunity for Test/Quality Engineer for a company located in Santa Cruz – CA, with an array of brain computer interface devices to address a range of neurological problems.  Candidate is required to have 2 to 5 years of medical quality system experience as well as sw/hw test experience in electromechanical systems.

Mechanical Engineer – Santa Cruz, CA
There is an exciting opportunity for Mechanical Engineer for a company located in Santa Cruz – CA, with an array of brain computer interface devices to address a range of neurological problems.  Candidate is required to have 2 to 5 years of medical device experience in electromechanical systems.

Senior R&D Engineer – San Jose, CA
There is an exciting opportunity for Senior R&D engineer in a fast growing company located in Northern San Jose, CA.  This is a once in a lifetime kind of an opportunity to be included in profit sharing and work on disruptive technology with an exciting team and a veteran leader.  Ten plus years of medical device hands on mechanical engineering experience and some polymer chemistry expertise is required to work on this novel drug delivery technology.

Senior Pharmacokinetic Scientist – San Jose, CA
There is an immediate opening for hands-on associate director or senior phamacokinetics scientist.  Requirements include experience with biologics, knowledge of GCP and regulatory guidelines, ability to work effectively with interdisciplinary project teams, familiarity with quantitative approaches in drug development, working knowledge of modeling software, and ability to plan, organize, and critically assess and/or perform PK/PD analyses. Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical or Chemical Engineering or related discipline and 7+ years Clinical Pharmacology experience is required.

Business Development Manager – Sunnyvale, CA
Exciting cancer genomics company has an opening for someone to head business development efforts.  The candidate will be responsible for selling of their genetic cancer risk test and must be willing to make cold calls and build partnerships with resellers and medical/wellness websites. Some hands-on social media marketing experience and knowledge of platforms to generate and drive traffic is required.

Embedded Software Engineer – Austin, TX

There is an immediate opportunity for Embedded Software Engineer for a company working on technology with a potential to alter future of care.

Responsibilities: Design & develop software for very low power, battery operated implantable & other medical devices consisting of a mixture of analog, digital and RF circuitry in highly integrated, low power embedded systems; design & develop externals and wereables for implantable & other medical devices; Document software design & implementation including requirement specs; Support V&V testing; Ensure compliance with FDA, ISO, AAMI & UL standards.

Requirements: BS in Electrical, Computer or Software Engineering; 15+ years experience in design & development of embedded systems including for medical devices; Strong expertise in embedded C/C++ programming including optimization for performance & memory usage; Experience developing applications which run a variety of OS/ RTOS targets; Experience in structural development environment with source control & bug tracking systems; Experience developing low level device drivers for hardware peripheral interfaces & devices like SPI, 12C, USB, LCD, ADC, DAC, RFIC; Experience with a variety of CPU architecture (Arm Cortex M3/M4 TI MSP430 etc. Must have experience with board bring up, effective use of hardware test equipment including logic analyzers, digital storage oscilloscopes etc. LabVIEW & related execution and test setup experience preferred.

For this opportunity, design experience with bare metal embedded systems under an FDA-compliant QMS is absolutely essential.

Senior Electrical Hardware Engineer – Austin, TX

There is an immediate opportunity for Electrical Hardware Engineer for a company led by veteran leaders, disruptive technology, and highly experienced team. This position will report to VP of product development.

Responsibilities: R&D design & development of implantable and associated wearable & external hardware using mixed signal, analog & digital techniques, sensors & actuators, and closed loop control systems; Develop wireless charging & wireless communications; Manufacturing including process development, qualification & validation, part/ component selection; Develop power efficient, reliable & hermetically sealed & packaged Class II/III implantable electronics to be compliant with regulatory & QA standards (FDA & ISO); Work in a matrixed & multi disciplinary organizational structure.

Requirements: BS in EE; 10+ years experience in design, development & implementation of electronics & mixed-signal hardware, firmware & software for implantable medical devices; Hands-on leadership in with electronics hardware and software, analog, digital, sensors, actuators, power management and wireless communications; Experience with qualified sensors for both implantable device function and for measuring physiological parameters; Experience with implantable device components like connectors, leads, cables, interconnectors, headers, electronics packaging, communication protocols & standards. Microwave programming a plus. Experience with EDA tools: sensors/ circuit design, simulation, layout, circuit and system prototyping & development; Experience implementing manufacturability & related process flows & controls; vendor selection for manufacturability of medical devices; Working knowledge of biocomaterials, drugs, drug delivery & mechanical technologies in support of multidisciplinary teams.

VP OF MARKETING – Sunnyvale, CA

A global company with a breakthrough solution in the fight against cancer has an immediate opening for VP, Marketing.  The company seeks to dramatically transform early cancer detection through simple & accurate blood tests.

Responsibilities: Develop & implement product & brand strategies; Drive commercial results; Work cross-functionally; Develop strategies/initiatives worldwide to drive growth; Lead creation and design of new product portfolio; Develop comprehensive marketing strategy for products across multiple channels, including direct to consumer and product segments; Develop, execute & manage cohesive geographic expansion plan taking into account market potential, clinical and regulatory pathways, exclusivity, and strategic alignment; Develop marketing strategy to ensure sales goals; Expand relations with KOLs & customers; Hire and lead Marketing team; Maintain industry awareness.

Requirements: Experience in launch & commercialization of innovative, first-in-class lab developed tests; Strong collaborator; Contribute to creation of a brand plan that enforces a highly collaborative and effective commercial organization. Qualifications required: BA plus 10+ years experience in diagnostic industry in conception, development & execution of marketing strategies for highly specialized products in China, Taiwan, India & S E Asia and US. Experience in building corporate brand from grounds up, in developing compelling data-driven pitch decks for various strategic recommendations, in presentations, in marketing to diverse customer segments, in mentoring, in “out of box” innovative thinking & strong customer orientation. MBA and fluency in English & Mandarin preferred.

Head of Asceptic Manufacturing – San Jose, CA

There is an immediate opening to head Asceptic Manufacturing for Drug Device company in San Jose, CA.  Requires strong engineering background and expertise in setting up asceptic manufacturing.  Opportunity for profit sharing in exciting technology company along with an opportunity to work with a top notch team and a veteran leader are great pluses.

PHARMACOLOGIST with Large Animal In-Vivo Survival Surgery Experience
San Jose, CA

Innovative life science company with several life saving technologies has an immediate opportunity for a pharmacologist for animal studies. DVM ok.

Leave a comment

JOBS – June, 2017



Image result for jobs
All US based opportunities require valid US work visa and prior experience in biomedical industry.  If interested in any opportunities below, please send me an email (resume as an attachment) and include position title in the subject line.  You can also find me on LinkedIn. (Or send me a message with title of the position that interests you, how it matches your background & your contact info). 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. Emails with proper subject line, some details in the body of the email to my hot mail address or linkedin will get quicker response.  Besides below opportunities, more opportunities are coming in Quality Engineering and Regulatory.

Test/ Quality Engineer – Santa Cruz, CA
There is an exciting opportunity for Test/Quality Engineer for a company located in Santa Cruz – CA, with an array of brain computer interface devices to address a range of neurological problems.  Candidate is required to have 2 to 5 years of medical quality system experience as well as sw/hw test experience in electromechanical systems. 

Mechanical Engineer – Santa Cruz, CA
There is an exciting opportunity for Mechanical Engineer for a company located in Santa Cruz – CA, with an array of brain computer interface devices to address a range of neurological problems.  Candidate is required to have 2 to 5 years of medical device experience in electromechanical systems.

Digital Marketing Manager – Sunnyvale, CA
Exciting cancer genomics company has an opening for someone to head digital marketing.  Hands-on social media marketing experience and knowledge of platforms to generate and drive traffic is required.

Director of Engineering – Hong Kong

There is an exciting opportunity for Director of Engineering for a robotic surgery company located in Hong Kong.  This is an opportunity to work with a great  team on cutting edge technology with a potential to alter healthcare in a meaningful way.  Significant stock options in addition to relocation package and salary commensurate with experience, makes it a very exciting opportunity for long or short stint in Hong Kong.

Responsibilities
Compile & conduct presentations on company’s products; Conduct technical reviews of products; Work with teams in marketing, product compliance and registration; Compile & conduct technical presentations, technological analysis reports; Identify technological trends; and Provide technical advice.

Requirements
5+ years hands-on product development experience in an ODM setting, preferably on products requiring integration of cross-discipline technologies, among high-precision multi-DoF mechanical drivetrains, real-time embedded control software, video systems and optic; and ability to build external strategic alliances & partnerships. Also required fluency in English. Highly preferred academic degree in two different engineering disciplines and MBA is an additional advantage.

Embedded Software Engineer – Austin, TX

There is an immediate opportunity for Embedded Software Engineer for a company working on technology with a potential to alter future of care.

Responsibilities: Design & develop software for very low power, battery operated implantable & other medical devices consisting of a mixture of analog, digital and RF circuitry in highly integrated, low power embedded systems; design & develop externals and wereables for implantable & other medical devices; Document software design & implementation including requirement specs; Support V&V testing; Ensure compliance with FDA, ISO, AAMI & UL standards.

Requirements: BS in Electrical, Computer or Software Engineering; 15+ years experience in design & development of embedded systems including for medical devices; Strong expertise in embedded C/C++ programming including optimization for performance & memory usage; Experience developing applications which run a variety of OS/ RTOS targets; Experience in structural development environment with source control & bug tracking systems; Experience developing low level device drivers for hardware peripheral interfaces & devices like SPI, 12C, USB, LCD, ADC, DAC, RFIC; Experience with a variety of CPU architecture (Arm Cortex M3/M4 TI MSP430 etc. Must have experience with board bring up, effective use of hardware test equipment including logic analyzers, digital storage oscilloscopes etc. LabVIEW & related execution and test setup experience preferred.

For this opportunity, design experience with bare metal embedded systems under an FDA-compliant QMS is absolutely essential.

Senior Electrical Hardware Engineer – Austin, TX

There is an immediate opportunity for Electrical Hardware Engineer for a company led by veteran leaders, disruptive technology, and highly experienced team. This position will report to VP of product development.

Responsibilities: R&D design & development of implantable and associated wearable & external hardware using mixed signal, analog & digital techniques, sensors & actuators, and closed loop control systems; Develop wireless charging & wireless communications; Manufacturing including process development, qualification & validation, part/ component selection; Develop power efficient, reliable & hermetically sealed & packaged Class II/III implantable electronics to be compliant with regulatory & QA standards (FDA & ISO); Work in a matrixed & multi disciplinary organizational structure.

Requirements: BS in EE; 10+ years experience in design, development & implementation of electronics & mixed-signal hardware, firmware & software for implantable medical devices; Hands-on leadership in with electronics hardware and software, analog, digital, sensors, actuators, power management and wireless communications; Experience with qualified sensors for both implantable device function and for measuring physiological parameters; Experience with implantable device components like connectors, leads, cables, interconnectors, headers, electronics packaging, communication protocols & standards. Microwave programming a plus. Experience with EDA tools: sensors/ circuit design, simulation, layout, circuit and system prototyping & development; Experience implementing manufacturability & related process flows & controls; vendor selection for manufacturability of medical devices; Working knowledge of biocomaterials, drugs, drug delivery & mechanical technologies in support of multidisciplinary teams.

VP OF MARKETING – Sunnyvale, CA

A global company with a breakthrough solution in the fight against cancer has an immediate opening for VP, Marketing.  The company seeks to dramatically transform early cancer detection through simple & accurate blood tests.

Responsibilities: Develop & implement product & brand strategies; Drive commercial results; Work cross-functionally; Develop strategies/initiatives worldwide to drive growth; Lead creation and design of new product portfolio; Develop comprehensive marketing strategy for products across multiple channels, including direct to consumer and product segments; Develop, execute & manage cohesive geographic expansion plan taking into account market potential, clinical and regulatory pathways, exclusivity, and strategic alignment; Develop marketing strategy to ensure sales goals; Expand relations with KOLs & customers; Hire and lead Marketing team; Maintain industry awareness.

Requirements: Experience in launch & commercialization of innovative, first-in-class lab developed tests; Strong collaborator; Contribute to creation of a brand plan that enforces a highly collaborative and effective commercial organization. Qualifications required: BA plus 10+ years experience in diagnostic industry in conception, development & execution of marketing strategies for highly specialized products in China, Taiwan, India & S E Asia and US. Experience in building corporate brand from grounds up, in developing compelling data-driven pitch decks for various strategic recommendations, in presentations, in marketing to diverse customer segments, in mentoring, in “out of box” innovative thinking & strong customer orientation. MBA and fluency in English & Mandarin preferred.

Head of Asceptic Manufacturing – San Jose, CA

There is an immediate opening to head Asceptic Manufacturing for Drug Device company in San Jose, CA.  Requires strong engineering background and expertise in setting up asceptic manufacturing.  Opportunity for profit sharing in exciting technology company along with an opportunity to work with a top notch team and a veteran leader are great pluses.

PRODUCT MANAGER, GENOMICS – Sunnyvale, CA

A global company with a breakthrough solution in the fight against cancer through novel and dramatically transforming early cancer detection through simple and accurate blood tests has an immediate opening for Product Manager. This breakthrough technology is already creating patient impact in Asia. Reporting to the VP of Marketing, the Product Manager will be a driver for key products and will be responsible for the product strategy as well as the design of all genomic products. Working closely with sales and cross functional leadership in R&D, clinical and medical functions, the candidate will develop initiatives worldwide to drive revenue growth.

Responsibilities: Define product strategy & roadmap and deliver product requirements with prioritized features; Develop the core positioning & messaging; work cross functionally to drive technical & clinical development of the product; understand competition & incentives for all stakeholders in the system to drive growth of the product; Create marketing communications materials for physicians; Brief & train sales force on product benefits & features; Work closely with marketing team in Asia to design & implement local programs to support product goals; Support marketing team in organizing special event & marketing campaigns; Manage company presence at conferences & tradeshows; Manage media, PR, digital marketing & social media campaigns  About 30% travel required.
Requirements: Background in molecular & cell biology, experience in healthcare product marketing or product management. Fluency in Mandarin desirable.

DIRECTOR OF R&D – San Jose, CA

There is an exciting opportunity for Manager/ Director of R&D with hands on mechanical engineering & polymer chemistry expertise.  The company is located in Northern San Jose, CA. This is a once in a lifetime kind of an opportunity to be included in profit sharing and work on disruptive technology with an exciting team and a veteran leader.

PHARMACOLOGIST with Large Animal In-Vivo Survival Surgery Experience
San Jose, CA

Innovative life science company with several life saving technologies has an immediate opportunity for a pharmacologist for animal studies. DVM ok.

Leave a comment

JOBS: May, 2017


Image result for jobsAll US based opportunities require valid US work visa and prior experience in biomedical industry.  If interested in any opportunities below, please send me an email (resume as an attachment) and include position title in the subject line.  You can also find me on LinkedIn. (Or send me a message with title of the position that interests you, how it matches your background & your contact info). 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. Emails with proper subject line, some details in the body of the email to my hot mail address or linkedin will get quicker response.

Embedded Software Engineer – Austin, TX

There is an immediate opportunity for Embedded Software Engineer for a company working on technology with a potential to alter future of care. 

Responsibilities: Design & develop software for very low power, battery operated implantable & other medical devices consisting of a mixture of analog, digital and RF circuitry in highly integrated, low power embedded systems; design & develop externals and wereables for implantable & other medical devices; Document software design & implementation including requirement specs; Support V&V testing; Ensure compliance with FDA, ISO, AAMI & UL standards.

Requirements: BS in Electrical, Computer or Software Engineering; 15+ years experience in design & development of embedded systems including for medical devices; Strong expertise in embedded C/C++ programming including optimization for performance & memory usage; Experience developing applications which run a variety of OS/ RTOS targets; Experience in structural development environment with source control & bug tracking systems; Experience developing low level device drivers for hardware peripheral interfaces & devices like SPI, 12C, USB, LCD, ADC, DAC, RFIC; Experience with a variety of CPU architecture (Arm Cortex M3/M4 TI MSP430 etc. Must have experience with board bring up, effective use of hardware test equipment including logic analyzers, digital storage oscilloscopes etc. LabVIEW & related execution and test setup experience preferred.

Senior Electrical Hardware Engineer – Austin, TX

 

There is an immediate opportunity for Electrical Hardware Engineer for a company led by veteran leaders, disruptive technology, and highly experienced team. This position will report to VP of product development.  

Responsibilities: R&D design & development of implantable and associated wearable & external hardware using mixed signal, analog & digital techniques, sensors & actuators, and closed loop control systems; Develop wireless charging & wireless communications; Manufacturing including process development, qualification & validation, part/ component selection; Develop power efficient, reliable & hermetically sealed & packaged Class II/III implantable electronics to be compliant with regulatory & QA standards (FDA & ISO); Work in a matrixed & multi disciplinary organizational structure.

Requirements: BS in EE; 10+ years experience in design, development & implementation of electronics & mixed-signal hardware, firmware & software for implantable medical devices; Hands-on leadership in with electronics hardware and software, analog, digital, sensors, actuators, power management and wireless communications; Experience with qualified sensors for both implantable device function and for measuring physiological parameters; Experience with implantable device components like connectors, leads, cables, interconnectors, headers, electronics packaging, communication protocols & standards. Microwave programming a plus. Experience with EDA tools: sensors/ circuit design, simulation, layout, circuit and system prototyping & development; Experience implementing manufacturability & related process flows & controls; vendor selection for manufacturability of medical devices; Working knowledge of biocomaterials, drugs, drug delivery & mechanical technologies in support of multidisciplinary teams.  

VP OF MARKETING – Sunnyvale, CA

A global company with a breakthrough solution in the fight against cancer has an immediate opening for VP, Marketing.  The company seeks to dramatically transform early cancer detection through simple & accurate blood tests.

Responsibilities: Develop & implement product & brand strategies; Drive commercial results; Work cross-functionally; Develop strategies/initiatives worldwide to drive growth; Lead creation and design of new product portfolio; Develop comprehensive marketing strategy for products across multiple channels, including direct to consumer and product segments; Develop, execute & manage cohesive geographic expansion plan taking into account market potential, clinical and regulatory pathways, exclusivity, and strategic alignment; Develop marketing strategy to ensure sales goals; Expand relations with KOLs & customers; Hire and lead Marketing team; Maintain industry awareness.

Requirements: Experience in launch & commercialization of innovative, first-in-class lab developed tests; Strong collaborator; Contribute to creation of a brand plan that enforces a highly collaborative and effective commercial organization. Qualifications required: BA plus 10+ years experience in diagnostic industry in conception, development & execution of marketing strategies for highly specialized products in China, Taiwan, India & S E Asia and US. Experience in building corporate brand from grounds up, in developing compelling data-driven pitch decks for various strategic recommendations, in presentations, in marketing to diverse customer segments, in mentoring, in “out of box” innovative thinking & strong customer orientation. MBA and fluency in English & Mandarin preferred.

Head of Asceptic Manufacturing – San Jose, CA

There is an immediate opening to head Asceptic Manufacturing for Drug Device company in San Jose, CA.  Requires strong engineering background and expertise in setting up asceptic manufacturing.  Opportunity for profit sharing in exciting technology company along with an opportunity to work with a top notch team and a veteran leader are great pluses.

PRODUCT MANAGER, GENOMICS – Sunnyvale, CA

A global company with a breakthrough solution in the fight against cancer through novel and dramatically transforming early cancer detection through simple and accurate blood tests has an immediate opening for Product Manager. This breakthrough technology is already creating patient impact in Asia. Reporting to the VP of Marketing, the Product Manager will be a driver for key products and will be responsible for the product strategy as well as the design of all genomic products. Working closely with sales and cross functional leadership in R&D, clinical and medical functions, the candidate will develop initiatives worldwide to drive revenue growth.

Responsibilities: Define product strategy & roadmap and deliver product requirements with prioritized features; Develop the core positioning & messaging; work cross functionally to drive technical & clinical development of the product; understand competition & incentives for all stakeholders in the system to drive growth of the product; Create marketing communications materials for physicians; Brief & train sales force on product benefits & features; Work closely with marketing team in Asia to design & implement local programs to support product goals; Support marketing team in organizing special event & marketing campaigns; Manage company presence at conferences & tradeshows; Manage media, PR, digital marketing & social media campaigns  About 30% travel required.
Requirements: Background in molecular & cell biology, experience in healthcare product marketing or product management. Fluency in Mandarin desirable.

DIRECTOR OF R&D – San Jose, CA

There is an exciting opportunity for Manager/ Director of R&D with hands on mechanical engineering & polymer chemistry expertise.  The company is located in Northern San Jose, CA. This is a once in a lifetime kind of an opportunity to be included in profit sharing and work on disruptive technology with an exciting team and a veteran leader.

PHARMACOLOGIST with Large Animal In-Vivo Survival Surgery Experience
San Jose, CA

Innovative life science company with several life saving technologies has an immediate opportunity for a pharmacologist for animal studies. DVM ok.

 

Leave a comment

%d bloggers like this: