JOBS: May, 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.

Regulatory Manager – San Jose, CA
Requires 8+ years of experience in pharma, ideally experience in biologics.

Clinical Trial Manager – San Jose, CA
Ideal experience: 8+ years experience in medical devices, ideal in neuromodulation,  running clinical trials, working with clinicians and medical centers.

Clinical Trial Manager – San Jose, CA
Ideal experience – 8+ years of hands on experience in running pharma trials at manager level. Running clinical studies in biologics is a major plus.

Manufacturing Engineer – San Jose, CA
Requires 8+ years of experience in medical device manufacturing.

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.

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.

JOBS – November, 2015

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

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

CLS Lab Manager – Santa Clara, CA

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

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

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

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

Director of Quality Engineering – Milpitas, CA

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

Director of Manufacturing Engineering – Milpitas, CA

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

Post-doc opportunity – San Jose, CA

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

Senior Biochem Scientist- San Jose, CA

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

Senior Quality Engineer – San Antonio, TX

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

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

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

Senior Clinical Data Manager – Dublin, CA

Clinical Supplies Contractor – Dublin, CA

JOBS — October, 2015

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

Director of Quality Engineering – Milpitas, CA

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

Director of Manufacturing Engineering – Milpitas, CA

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

VP of Engineering – Santa Clara, CA

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

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

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

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

Clinical PK Scientist – Dublin, CA

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

Responsibilities: 

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

Qualifications:

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

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

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

Biostatistical Programming Contractor/ Biostatistician – Dublin, CA 

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

Immediate contract Engineering Opportunities – San Jose, CA

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

Opportunities in India are posted in August JOBS posting.

Jobs – September, 2015

Please see below some of my immediate opportunities.  Post doc and contract opportunities are for candidates located in the United States.  But there are some new opportunities below that are located in India, for anyone wishing to do a stint in India, in very exciting, cutting edge multinational.  When sending your resume, please include details on your current compensation and compensation expectations.  Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com.

VP of Engineering – Santa Clara, CA

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

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

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

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

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

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

Immediate contract Engineering Opportunities – San Jose, CA

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

Opportunities in India are posted in August JOBS posting.

Jobs – July, 2015

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

I have new opportunities in California and Texas; many of them are in in engineering in Quality, Manufacturing, and Mechanical and other job openings in Biochemistry, Physiologist with animal surgery experience and in manufacturing and document control of drug delivery type of medical devices.  I will post details as and when I get full descriptions.  All opportunities are for candidates located in the United States.  When sending your resume, please include details on your current compensation and compensation expectations.  Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com.  See below a list of additional opportunities.

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

Clinical Trial Manager/Sr CTM – Asthma (12-Month Contract) – Berkeley, CA

Overview:  Responsible for managing the full scope of proper study conduct including, but not limited to, protocol development to final report, regulatory filing and/or publications, coordinating cross functional efforts in the administration and progress of Phase 1 to 4 clinical trials.  Additional responsibilities include trial start-up, conduct, and close-out activities in order to achieve program objectives and goals.

The incumbent will use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.  May determine methods and procedures on new assignments.  Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.  Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Responsibilities:
* Lead clinical trial project execution for asthma programs to ensure that trial timelines, costs, and quality metrics are met.
* Serves as primary contact for functional area representatives in managing protocol execution.
* Manage the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments.
* Forecast and oversee clinical supplies, e.g. study drug.
* Manage study milestones to ensure accurate tracking and reporting of study metrics.
* Oversee ongoing service provider management (e.g., CROs, IVRS, Central Labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
* Create and manage clinical trial budgets in collaboration with manager and the Vice President of Clinical Operations.
* May provide study-specific direction and mentoring to CRAs and CTAs.
* Collaborate with Clinical Quality Assurance to maintain quality standards in compliance with regulatory requirements/guidance’s and adherence to SOPs and ICH/GCPs; participate in ongoing process improvement initiatives.
* Manage adherence to ICH/GCP/local regulations.
* Participate in clinical operations initiatives and programs.
* Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
* Other duties as assigned.

Qualifications:
* Bachelor’s Degree with at least 5 to 8 years of CRA experience for the manager level with at least 1 year of staff management experience.  The senior manager level requires 10+ years of combined CRA and CTM experience and 3 years direct staff management experience is required.
* Experience in inflammatory diseases, specifically Asthma and/or Chronic Obstructive Pulmonary disease (COPD) is required.
* Excellent communication skills to effectively disseminate information within clinical as well as other functional areas as appropriate.
* Experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management.
* Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
* Excellent organizational and negotiation skills.  Proven ability in creative problem-solving and possess sound judgment.
* Team oriented and collaborates effectively with the Clinical Operations study team, cross-functional team members, and external partners.
* Proficient computer skills, specifically with Microsoft Office Suite that includes Word, Excel, PowerPoint, and Outlook.
* Working knowledge of MS Project for development and update of clinical study timelines.
* The incumbent in this position must be able to remain in stationary position 50% operating a computer and other office equipment and needs to occasionally move about the office for meetings, to access files, and other office equipment.
* Willing to travel – anticipate up to 25%.

Senior Mechanical Engineer – San Jose, CA
12+ years of Class III medical device is required, with experience in machining, injection molding etc.

Biochemist – San Jose, CA

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

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

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

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

Senior Mechanical Engineer – San Jose, CA

This is an exciting opportunity to work at grounds level with a veteran leader, in innovative drug delivery space.  Minimum 10 years of medical device experience is required.

Opportunities in Berkeley, CA

If you are interested in any of the opportunities below in Berkeley, CA then send me an email with resume and I will be happy to share more details.

BioChemist – San Jose, CA
Scientist I-III, Potency Assay Development – 6-12 month contract
Scientist I/III Protein Analytics (Contract 6-12 months)
Senior Manager / Associate Director, Regulatory Affairs (Clinical)
Director, GxP & Research Applications
Director, SG&A Applications (Finance, Supply Chain, HRIS, and Reporting Systems)
Director/Sr. Director Corporate Communication
Medical Writing QC Reviewer – 12 month contract (x2)
Clinical Trial Manager/Sr CTM – Asthma (12-Month Contract)
Copy Editor – 6-12 month Contract
Director/Sr. Director, Marketing
Laboratory Assistant
Vice President and General Counsel
Sr. Director, Quality Assurance – Commercial
Director/Sr. Director,Quality Assurance, Development
Specialist/Sr. Specialist/Manager – Quality GCP Compliance
Post-Doctoral Fellow (Senior), Analytical Development – Protein Analytics and Characterization

JOBS – April, 2015

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

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

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

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

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

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

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

Ruby on Rails Engineer – San Mateo, CA

Senior Electrical Engineer – Austin/ San Antonio – TX

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

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

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

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

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

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

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

QUALITY ENGINEER – Santa Cruz, CA

See full description in March Job posting.

Senior Quality Engineer – Austin/ San Antonio – TX

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

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

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

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

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

Aligning value proposition: From Preclinical to Market for Medical Devices

Tim Pelura, CEO, Surpass Preclinical CRO talked on how medical device companies can align their strategy, from preclinical to market, with a focus on the value proposition, at www.bio2devicegroup.org event.

We are operating under a new reality now where power has shifted to the payers and the providers, said Pelura.  Medical device companies are evaluated based on safety and procedural efficacy as well as cost and value.  Increasingly heightened regulatory scrutiny and tightening FDA regulations have led to increase in audits (which were up 40% in the last year) and warning letters are (which were up 24% over the last 2 years).  Due to regulatory and reimbursement challenges, medical device companies are focusing their R&D efforts on improving already approved devices, rather than developing innovative new products.  Meanwhile startups are finding the landscape challenging due to funding challenges and increasing costs of bringing new products to market.

Healthcare Infostep (Photo credit: Wikipedia)

Inkeeping with the reality of pressures on payers that are transmitted down, new healthcare delivery models are emerging, and therefore, patient pathways are being modified to obtain to obtain better outcomes, with less cost.  Medical device companies will need to work with new business models, that solve significant problems and reduce overall costs.  Companies seeking growth will need to expand their offerings to target underserved populations and lower socioeconomic classes.

In essence, it is about the value proposition offered by the new product or service, “what benefit you provide for who and how you do it uniquely well”, said Pelura.  He advised, these “must-haves” in a business pitch, “describe your target buyer, the problem you are seeking to solve, and why you do it better than the alternative”.

Pelura walked the audience through the process of arriving at the value proposition.  First, companies must define the problem they are seeking to solve and identify correctly the need to solve the problem.  Next, they should try to go after obvious problems, rather than aspirational or “good to solve” problems.  And finally, they should try to address acute or critical problems.

In defining a solution, they should try to generate many ideas and then measure the viability of customer adoption of each idea using gain/pain ratio; what the customer stands to gain versus the cost of adoption of the new solution.  The best solutions are those that offer game-changing benefits, with minimal modifications to the existing process or environments, said Pelura.  Go for “Disruptive Innovations, that are Non-Disruptive to Adopt”, advised Pelura.   Medical device companies must visualize the entire process or patient pathway to ensure that the new solution would cause minimal disruptions, in the whole process.

While new technologies often emerge with a focus on engineering and progress to bench testing and then plan preclinical, and clinical strategies and only then consider navigating regulatory, market, and reimbursement challenges; in actuality, they should invert the process.  They should begin with considering reimbursement challenges, analyze the competitive landscape, study the market opportunity, give thoughtful consideration to the regulatory challenges, then consider clinical and preclinical strategy, before embarking on prototype and bench testing.  Because if the value proposition is wrong then a company can end up with a product that no one wants or needs, resulting in considerable waste of precious innovation dollars and time, said Pelura.

Speaking of Surpass, Pelura shared that preclinical Contract Research Organization, Surpass is doing things differently.  While having deep expertise as a preclinical CRO in helping medical device companies with their preclinical in vivo and human cadaveric studies, Surpass also seeks to impact the system, by probing and assisting their clients with questions that go to the value proposition.  Surpass assists the clients in designing the most translatable preclinical study by understanding issues of clinical end points, product’s desired features and characteristics, all the while keeping in mind who would be operating the device, studies and activities that might need to be completed to demonstrate the products, performance, safety, and efficacy, as well as data that would be required to drive reimbursement and more.  This novel process ensures that any preclinical testing performed is aligned to the new product’s value proposition, hence helping save valuable healthcare innovation dollars.  

The session was followed by Q&A.