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Principal Quality Engineer

Company: Pulse Biosciences
Location: Hayward
Posted on: November 24, 2022

Job Description:

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 world-class company.
  • 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 by:
    • 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 testing.
    • 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 preferred.
      • 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 & Performance Testing).
      • Hands-on experience with catheter-based devices from development through commercialization.
      • Work experience in a startup environment is an asset! You'll experience:
        • Purposeful and rewarding work collaborating with bright and curious minds!
          • Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!
          • A variety of health insurance plans and supplemental insurance options.
          • 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 activities.
          • 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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