Principal Quality Engineer
Company: Pulse Biosciences
Posted on: November 24, 2022
Pulse Biosciences (Nasdaq: PLSE) is a novel bioelectric medicine
company committed to health innovation that has the potential to
improve the quality of life for patients. The Company's proprietary
Nano-Pulse Stimulation (NPS) technology delivers nano-second pulses
of electrical energy to non-thermally clear cells while sparing
adjacent non-cellular tissue. The CellFX System is the first
commercial product to harness the distinctive advantages of NPS
technology to treat a variety of conditions for which an optimal
solution remains unfulfilled. At Pulse, we:
- Exist to make a positive difference in the lives of patients,
physicians, healthcare providers, shareholders and our Pulse
Biosciences team members.
- Take pride in hiring the best and brightest minds to our
- Are individuals who are creative, forward-thinking, and who
approach challenges with an innovative attitude that will excel in
our culture. About the RoleAs the Principal Quality Engineer, you
will participate in the implementation and maintenance of QSR (21
CFR 820) and ISO 13485 quality systems and qualification activities
of the Company's CellFX system, disposable and reusable medical
devices in support of the Company's research and development,
manufacturing, regulatory, and clinical affairs efforts. In
addition, you will support the development and implementation of
quality systems and compliance activities You will make an impact
- Providing expertise and guidance to product development and
manufacturing teams in the areas of design assurance, design
controls and compliance.
- Developing, establishing, and maintaining quality engineering
methodologies, systems and practices that meet Pulse Biosciences'
customer and regulatory requirements.
- Leading the risk management process in establishing risk
management plan, conducting risk evaluation and analysis, and
creating risk management report.
- Managing all aspects of biocompatibility testing and
sterilization including creating of test protocols and executing of
- Investigating, identifying, and implementing best-in-class
quality engineering practices gives you a sense of purpose! To be
successful, you will bring:
- BS degree in engineering, science or equivalent.
- 10+ years working as a Quality Engineer within a Class III/II
medical device industry. Cardiovascular device experience strongly
- Extensive work experience with FDA QSR (21 CFR Part 820 & Part
11) and ISO 13485/MDD requirements are required.
- Extensive knowledge and experience in Risk Assessment (ISO
14971) practices and implementation.
- Knowledge and experience in ISO 10993 standard series
(Biocompatibility), AAMI/ISO 11135 & 11137 (EO & Irradiation
sterilization), ISO 11607 & ASTM D4169 (Sterile Packaging &
- Hands-on experience with catheter-based devices from
development through commercialization.
- Work experience in a startup environment is an asset! You'll
- Purposeful and rewarding work collaborating with bright and
- Learning culture focusing on professional and personal growth
and development that you can only get in a startup-like
- A variety of health insurance plans and supplemental insurance
- 401k retirement savings plan.
- Stock options awards and ESPP program.
- Paid time off, paid holidays, and flexible work schedule.
- Wellness program with free onsite gym, mindfulness classes and
- A commitment to providing a respectful work environment to our
diverse workforce. We provide equal employment opportunities (EEO)
to all persons regardless of race, age, color, gender, sexual
orientation, national origin, physical or mental disability,
religion, or any other characteristic protected by federal, state
or local law. We will make reasonable accommodations for qualified
individuals with disabilities. Pulse Biosciences currently
maintains a policy requiring all United States-based employees to
be fully vaccinated against COVID-19. In accordance with applicable
law, Pulse Biosciences will consider reasonable accommodations to
employees who qualify as required under federal, state and local
law where it is not an undue hardship to the company to do so. Our
corporate headquarters is located in Hayward, California. To learn
more about us, visit our website at . LOCAL CANDIDATES ONLY
Principals only; unsolicited candidate submissions from recruiters
or third-party agencies will be considered free referrals.
Keywords: Pulse Biosciences, Hayward , Principal Quality Engineer, Engineering , Hayward, California
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