Jobs – April, 2014

For the opportunities below, please send resume at wd_darshana at hotmail dot com.  Please indicate in the email how closely the job description matches your background and identify gaps, if any.  Also, indicate your current compensation and compensation expectations.  Please note: All below opportunities require several years of industry experience and are only for local candidates, with valid US work visa (when need arises for applicants with other types of visas, I will mention that under that specific opportunity).  Also note, opportunities at the top are hot and the ones lower down may be at various stages of being filled or not burning needs.

Quality Engineering opportunities- Middleton, MA

A company located near Middleton, MA, and recognized as a pioneer & global leader in healthcare technology & innovation for assisting or replacing the life-sustaining pumping function of the failing heart, has following immediate Quality Engineering opportunities.

Quality Engineer – Console Program Support

Requirements:  Bachelors in EE & 5+ years implantable medical device experience and Design Control & risk management experience required.  CQE or CRE certifications are preferred.  Comp: $80-95K
Functions: Understand customer complaint trends & patterns for root cause understanding & corrective actions; Program support for console includes review of design/software verification & validation protocols & reports; conduct design control compliance reviews, performs risk analysis, and FMEAs; Instill reliability mindset within team & provide guidance on reliability methods to team.

Quality Engineer – Disposables Program Support

Requirements:  Bachelors in EE highly desirable.  1 year medical device experience & CQE or CRE certifications are highly preferred. Comp: $60-85K
Functions: Understand customer complaint trends & patterns for root cause understanding & corrective actions; program support on heart pump disposables including review of design & process verification and validation protocols & reports; conducts design control compliance reviews, performs risk analysis, and FMEAs.

Senior Embedded Development Programmer – Mountain View, CA — Hot

A top notch product development company with a reputation for completing difficult projects on time and on budget, has an immediate opening for a programmer. The company consults for companies making wearable devices, home health, products for the aging, medical devices etc & is known for work with sensors, wireless, and motion control.

Requirements:  10+ years experience in engineering design; Embedded programming skills on Windows and/or Linux; Experience with wide range of processors; Familiarity with digital circuits; Ability to design digital circuits. Ability to design analog circuits & supervisory experience would be a plus. The person needs to enjoy working with customers and have good communication skills.  The person needs to work well on a team of high performing engineers.  The person needs to be organized.  The person needs to work well with others and be flexible as schedules and priorities change.

Director Quality Engineering – San Jose, CA

There is an exciting opportunity for Director Quality Engineering with strong capability and experience developing quality innovative medical devices.  This position is responsible for effectively leading multi-project quality engineering efforts of the organization through technical expertise, interpersonal skills and a clear vision for execution.

Responsibilities: Manage resources to accomplish multi-project product research, development and manufacturing; Contribute to strategy and management of GMP/GLP operation; Provide Quality Engineering support as necessary to meet organizational objectives; Maintain quality management systems necessary for development, including clinical evaluation; Develop quality plans and data analyses for execution and review with leadership team; Develop test strategies DOEs and test protocols to test developmental medical devices and manufacturing processes; Work with R & D and Operations to establish quality requirements at all phases of product/process development and manufacturing; Design, schedule, and if necessary, performs specific testing for existing and new products including supporting design and process validations, qualifications and first article inspections; Conducts supplier evaluations including supplier audits; Ensure that appropriate level of quality/reliability in purchased components is specified; Identify product/process problems and ensure appropriate corrective actions are taken and verified to be effective in eliminating problem; Remain current on developments in field(s) of expertise and industry trends; Mentor junior staff members

Skills Required: Demonstrated leadership of technical teams in medical device field; Demonstrated aptitude for and mastery of Quality Engineering principles; Demonstrated problem solving skills in a multidisciplinary environment; Exemplary analytical, organizational, written and oral communication skills; Proficient with statistical analysis for engineering and manufacturing; Strong ability to operate independently and as a team member; Teamwork: ability to work closely and effectively with team members and colleagues across engineering as well as non-engineering disciplines such as biochemistry, physiology, pharmacology and chemistry; Knowledge of implantable medical device design control and manufacturing processes ; Deep experience in safety standards for a variety of medical device types; Knowledge of biocompatibility, packaging and sterilization quality assurance; Demonstrated ability to interface effectively with professionals in the medical and biological sciences; Demonstrated knowledge of sound design principles, regulatory requirements, and product and process validation procedures; Demonstrated proficiency with computer aided design software and hardware familiarity. Formal training on systems and software is desired.

Also required: Bachelor’s degree or higher in Engineering; Ten years minimum experience in medical device engineering (Quality, R&D and Manufacturing) with demonstrated capability and thorough understanding of quality management; Three years minimum direct personnel management and related leadership experience; ASQ Certified Quality Engineer certification preferred; Must have experience in GMP electro-mechanical product design and manufacturing; Requires highly developed leadership skills and experience, including the ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones.  Must be skilled at delegation, follow-up, and team building.

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QA Manager – Mount Laurel, NJ

An innovative medical device company working on treatment of chronic heart failure (“CHF”), has an immediate opening for a QA Manager.  Salary commensurate with experience and will be in the range of $125-145K.

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

Requirements: Minimum Bachelors level degree with 8-10 years’ experience in Quality area or related experience in medical device arena; Good working knowledge of domestic and international requirement and regulations; Excellent organizational skills and analytical and problem solving abilities; Strong verbal and writing skills and good interpersonal and leadership skills; Strong PC skills include Windows environment, Excel and internet.  Spanish language skills desirable.

Post Doc Opportunity – TX & CA 

There are immediate exciting opportunities that can lead you a fantastic career path in medical device engineering.  A medical device company, found by a veteran leader of several successful companies, has several post-doc openings in Biomedical with Electronics/ Electrical Engineering – with experience in heart/ brain related implantable devices in Texas and couple of opportunities with broad Biomedical/ Mechanical and/or Chemical Engineering background.  Hands-on experience is essential.  For Electronics Engineering, experience with hands-on circuit design, embedded systems design, prototype building or experience with battery-powered, low powered systems, etc. may be desirable.  The company is working on exciting cutting edge technology to deliver large drug molecules orally.  That and other research products pertain to solutions that are a unique blend of traditional device technologies such as electronics, software, mechanical engineering, and material science, as well as pharmaceuticals, protein chemistry and cell biology.  Focusing on a broad range of technology and scientific disciplines, the company is seeking to address most complex unsolved or poorly treated clinical needs with highly innovative novel solutions.

JOBS – December, 2013

For the opportunities below, please send resume at wd_darshana at hotmail dot com.  Please indicate in the email how closely the job description matches your background and identify gaps, if any.  Also, indicate your current compensation and compensation expectations.  Please note: All below opportunities require several years of industry experience and are only for local candidates, with valid US work visa (when need arises for applicants with other types of visas, I will mention that).  Also note, opportunities at the top are hot and the ones lower down may be at various stages of being filled or not burning needs.  I am awaiting more job descriptions and will keep adding.   Leads appreciated.

ios/ Android Developers – Bay Area, CA
Immediate need for health-IT company.

Senior and Junior Bioinformatics Scientists – San Ramon, CA

An organization near San Ramon, CA, dedicated to leveraging a range of transformational digital medical technologies in medical imaging and information technologies, medical diagnostics, patient monitoring, disease research, drug discovery & biopharmaceutical manufacturing technologies, has an immediate openings for Bioinformatics Scientists at Senior and Junior level.  Below description is for senior role.

Responsibilities: Bioinformatics developer will work with scientists & engineers for development of systems software within medical diagnostics. The position may also develop distributed software application for subsystems that enable the business strategic imperatives.  Essential functions: Develop robust bioinformatics software solutions to support company’s medical diagnostic activities; Work closely with systems teams in requirements gathering & software design; Interact with global teams to promote consistency & maximize synergies across common software platforms; Design & build strong testing infrastructure to minimize dependency on hardware availability; Leverage DFR for software, Agile & Lean software development methodologies to drive reliability upstream into the product development life cycle.

Requirements: MS or Ph.D. in Bioinformatics or Molecular Biology with a minor in Computer Science, Statistics or Computational Biology; 5+ years experience in combining knowledge of chemistry, physics, and/or biology with software engineering; 3+ years experience in programming using Pearl and/or Python; 2+ years experience with SQL, preferably MySQL; 2+ years experience with statistical programming (e.g. R, MATLAB).

Regulatory Affairs Director – Mount Laurel, NJ, & Orangeburg, New York (and another similar opening in Bay Area, CA)
(mention location preference when sending in the CV)

There is an immediate opening for Regulatory Affairs Director in a medical device company with innovative treatment of chronic heart failure built around CCM technology.  RA Director Will be responsible for RA and for Quality systems.

Responsibilities: Domestic & international submissions & approvals for all new & existing products; Assuring compliance with domestic & international quality and regulatory requirements; Assistance with design & implementation of clinical trials to support new & existing products; Represent company with FDA, Notified Body &  international regulatory agencies regarding company’s regulatory strategies & submissions; Determine strategy, content & structure of domestic & international regulatory filings & quality assurance strategies; Maintain quality system & current product documentation & labeling in compliance with new standards, directives & requirements; Assist in design & implementation of clinical studies in support of new & existing products.  Act as liaison with clinical function; Represent the company with all domestic & international regulatory agencies including all verbal & written communication to & from the company; make all final decisions regarding all Quality System related activities; Review all product complaints & ensure timely reporting of those events to domestic & international regulatory agencies as necessary; Review & revise quality system documentations; Schedule, ensure completion of, manage & respond to all audits; Ensure training of employees on Quality Systems Regulation & key international regulations & standards; Manage the program for handling product returns, returned product evaluations (repair/rework, where applicable), complaints & customer feedback in accordance with internal policies and procedures; Maintain ISO 13485:2012 facility registration in accordance with applicable standards; Participate in product development teams on behalf of Regulatory & Quality Systems; Ensure that the Quality Systems function is carried out in accordance with GMP & ISO directives; Prepare &  submit regulatory submissions to obtain approval to conduct domestic & international clinical investigations & to seek regulatory approval to commercialize new & existing devices & their accessories.

Requirements: Bachelor in science / engineering with at least 5 years’ experience in Regulatory/Clinical/Quality area or related experience; Regulatory/Clinical/Quality experience with Class 3 medical device; Regulatory experience in the Implantable field – highly preferable; Excellent working knowledge of domestic & international requirements, regulations & standards applicable to medical electrical devices – highly desirable; Proven experience with at least one complete medical device submission to a EU Notified body and the US FDA involving a device subject to the 60601-1 3rd edition standard; Thorough understanding of the MDD (Medical Device Directive); Previous direct interaction with the FDA & an EU Notified Body; Excellent working understanding of requirements & implementation of Quality Systems compliant with US & international requirements for medical device manufacturers; Previous experience assuring that the Quality Systems function is carried out in accordance with GMP & ISO directives; Ability to analyze & perform commercial risk management in the context of regulatory & quality requirements.

Director of Quality Assurance – Palo Alto, CA

Details to follow.

Senior Manager/ Director of Mechanical Engineering – San Jose, CA

There is an immediate opening for hands-on Director of R&D Mechanical Engineering in an early stage company developing a novel approach for the oral delivery of large drug molecules.  This position will be responsible for building the team and effectively leading multi-project R&D efforts of the organization through technical expertise, interpersonal skills & a clear vision for execution.  Stock options and cutting edge technology makes it highly attractive opportunity for the right candidate.

Responsibilities: Manage resources to accomplish multi-project product research & development; Provide Mechanical Engineering support to meet R&D objectives; Remain current on developments in field(s) of expertise and industry trends; Actively pursue development of corporate IP; Identify future product opportunities; Develop plans & analyses for execution and review with leadership team; Maintain & update appropriate controlled documentation; Mentor junior staff members.

Skills & Experience: Demonstrated leadership of technical teams in medical device field; aptitude for & mastery of Mechanical Engineering principles; problem solving skills in a multidisciplinary environment; Proficient with statistical analysis for engineering and manufacturing; ability to work closely with team members across engineering & non-engineering disciplines such as biochemistry, physiology, pharmacology & chemistry; Knowledge of plastic manufacturing processes including injection molding, thermoforming, casting, machining, extrusion etc.; Knowledge of metals & alloys used in medical devices and processing techniques such as brazing, laser welding & cutting, electropolishing, electroplating, machining etc.; Deep experience in polymer processing, catheter design & fabrication, including knowledge of polymer joining, fusing, die cutting, adhesives etc.; Knowledge of biomaterials & coatings suitable for implantation; Knowledge of packaging & sterilization techniques; ability to interface effectively with professionals in the medical and biological sciences; knowledge of sound design principles, regulatory requirements, and product and process validation procedures; proficiency with computer aided design software & hardware. Formal training on systems & software is desired.

Also required: Bachelor’s degree or higher in Mechanical Engineering; 10+ years experience in engineering and product development with demonstrated capability & thorough understanding of the medical device product development process; Three years minimum direct personnel management & related project leadership experience; ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines & develop, monitor and live within budgets as well as ability to forecast major milestones. Must be skilled at delegation, follow-up, and team building.

Director Quality Engineering – San Jose, CA

There is an exciting opportunity for Director Quality Engineering with strong capability and experience developing quality innovative medical devices.  This position is responsible for effectively leading multi-project quality engineering efforts of the organization through technical expertise, interpersonal skills and a clear vision for execution.

Responsibilities: Manage resources to accomplish multi-project product research, development and manufacturing; Contribute to strategy and management of GMP/GLP operation; Provide Quality Engineering support as necessary to meet organizational objectives; Maintain quality management systems necessary for development, including clinical evaluation; Develop quality plans and data analyses for execution and review with leadership team; Develop test strategies DOEs and test protocols to test developmental medical devices and manufacturing processes; Work with R & D and Operations to establish quality requirements at all phases of product/process development and manufacturing; Design, schedule, and if necessary, performs specific testing for existing and new products including supporting design and process validations, qualifications and first article inspections; Conducts supplier evaluations including supplier audits; Ensure that appropriate level of quality/reliability in purchased components is specified; Identify product/process problems and ensure appropriate corrective actions are taken and verified to be effective in eliminating problem; Remain current on developments in field(s) of expertise and industry trends; Mentor junior staff members

Skills Required: Demonstrated leadership of technical teams in medical device field; Demonstrated aptitude for and mastery of Quality Engineering principles; Demonstrated problem solving skills in a multidisciplinary environment; Exemplary analytical, organizational, written and oral communication skills; Proficient with statistical analysis for engineering and manufacturing; Strong ability to operate independently and as a team member; Teamwork: ability to work closely and effectively with team members and colleagues across engineering as well as non-engineering disciplines such as biochemistry, physiology, pharmacology and chemistry; Knowledge of implantable medical device design control and manufacturing processes ; Deep experience in safety standards for a variety of medical device types; Knowledge of biocompatibility, packaging and sterilization quality assurance; Demonstrated ability to interface effectively with professionals in the medical and biological sciences; Demonstrated knowledge of sound design principles, regulatory requirements, and product and process validation procedures; Demonstrated proficiency with computer aided design software and hardware familiarity. Formal training on systems and software is desired.

Also required: Bachelor’s degree or higher in Engineering; Ten years minimum experience in medical device engineering (Quality, R&D and Manufacturing) with demonstrated capability and thorough understanding of quality management; Three years minimum direct personnel management and related leadership experience; ASQ Certified Quality Engineer certification preferred; Must have experience in GMP electro-mechanical product design and manufacturing; Requires highly developed leadership skills and experience, including the ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones.  Must be skilled at delegation, follow-up, and team building.

Patent Attorney – Sunnyvale, CA

Innovative medical device company with a broad line of product portfolio, has an opening for Senior Patent Attorney for VP level position.  Must have 15+ years of medical device and biotech patent prosecution experience in a law firm.

Research Engineer – San Francisco, CA

A company that has developed advanced consumer health sensing technology, has an immediate opening for research engineer.  Responsibilities include, research and implement cutting edge physiological sensors and algorithms and work closely with research and device teams to integrate research into company’s consumer product portfolio.

Requirements: MS or PhD in biomedical engineering, electrical engineering, or related discipline; Minimum of 2-4 years (or academic equivalent) experience in physiological data collection, interpretation and analysis; Proficient in common signal processing techniques including time series analysis, adaptive filters, and noise cancellation; Demonstrated ability in a scientific computing language (e.g. Python, R, Matlab).
Also preferred: Experience developing algorithms for  physiological signals such as heart rate, temperature, perspiration or body motion accelerometry; Proficiency with machine learning and statistical modeling; Experience with data handling and storage, e.g. NoSQL database systems

Software Developers – SF Bay Area (contract, part-time)

Big data and machines are revolutionizing the way we operate. A software company that provides innovative, modular, scalable and world class solutions, in this industrial-internet paradigm, by leveraging state of the art sensor technologies, cloud computing, big data analytics, and complex event processing, is now scaling in pre-funding stage. Some of the clients include Cisco Systems, Applied Mateirals, Huawei, Agilent, HP, Foxconn, Fletronics, and Sanmina that are using this software to transform their engineering and manufacturing operations. The company is expanding core engineering and product development team and looking for high caliber, senior software developers, with interest in working with cutting edge technologies in a high energy entrepreneurial environment.

Responsibilities include: Being involved in all stages of SDLC including analysis, design, implementation, testing, documentation, and release; Participate in multiple projects with changing requirements; and Maintain contact with clients/ partners to provide solution support and updates.

Requirements include: 4-6 years of software development experience; Software Development experience; ASP.NET with MVC, JQuery; Comfortable in data modeling, developing stored procedures, and triggers; and Readiness to learn new technologies quickly. Windows Workflow Communication Foundation 4.0; Biztalk RFID server skills; Windows Mobile Development experience; and Exposure to Windows Azure.

The position is located in the San Francisco Bay Area. Telecommute is okay but may need to attend client team meetings. Duration: 6-12 months to full-time. Terms: 1099, corp-to-corp, contract-to-hire, no visa sponsorships but OPT visa may be ok. Pay: rate negotiable. Open to considering excellent part-time candidates.

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