Principal Quality Engineer

Location
Hayward, CA, United States
Posted
Jun 14, 2021
Ref
1059
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.

We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members. We take pride in hiring the best and brightest minds to our world-class company. Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture.
Position Summary:

The Principal Quality Engineer will participate in the implementation and maintenance of QSR (21 CFR 820) and ISO 13485 quality systems and qualification activities of CellFX system, disposable and reusable medical devices in support of the Company’s research and development, manufacturing, regulatory, and clinical affairs efforts. In addition, this individual will support the development and implementation of quality systems and compliance activities.
Essential Duties and Responsibilities:
  • Provide expertise and guidance to product development and manufacturing teams in the areas of design assurance, design controls and compliance.
  • Develop, establish, and maintain quality engineering methodologies, systems and practices that meet Pulse Biosciences’ customer and regulatory requirements.
  • Proactively investigate, identify, and implement best-in-class quality engineering practices.
  • Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
  • Develop and validate measurement methods, monitor design control standards, facilitate, and perform internal audits, perform statistical analysis, and participate in MRB as appropriate.
  • Lead the review of process and product quality performance, working in concert with various departments.
  • Manage all aspects of Biocompatibility testing, reusable Cleaning, and Sterilization including creating of test protocols and executing of testing.
  • Development of standard operating procedures, and training.
  • Design and implement methods and procedures for inspecting, testing, and evaluating components, subassemblies, and final assemblies.
  • Supervise and monitor Pulse Biosciences various quality processes such as CAPA, supplier quality management, GMP compliance activities.
  • Coordinate internal audits, supplier audits, and other regulatory compliant activities.
  • Support management review activities, regulatory audits including Notified Body audit (MDSAP) and assist with preparation of regulatory submissions.
  • Assist with development of product labeling, UDI compliance, translation, and investigator brochures for commercial and clinical studies.
  • Carry out responsibilities in accordance with the organization’s policies and applicable laws.
  • Support the Pulse Biosciences Quality Policy and Quality System.
  • Other duties as assigned.
Education and Experience:
  • BS degree in engineering, science or equivalent.
  • 10+ years’ experience working as a Quality Engineer within the medical device industry.
  • Must have extensive work experience with FDA QSR (21 CFR Part 820 & Part 11) and ISO 13485/MDD requirements are required.
  • Must have 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).

Skills, Abilities, and Other Requirements:
  • Mastered the use of quality disciplines, tools, and methodologies.
  • Must also have working knowledge and experience in the following areas:
    • Design Control
    • Design & Process Validation
    • Risk Management
    • Biocompatibility
    • Sterilization Validation
    • Packaging Validation
    • Quality System Compliance & Auditing
    • Complaint handling
    • MDR/Vigilance Reporting
    • CAPA management
    • Auditing
  • Proficient knowledge and skill in Microsoft Office Suite applications.
  • Excellent oral written communication skills and critical thinking skills.
  • Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
  • Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
  • Ability to travel up to 10% of the time. Overnight and/or international travel may be required.
  • Ability to lift 10-15 pounds.


Our corporate headquarters is located in Hayward, California. To learn more about us, visit our website at www.pulsebiosciences.com.

At Pulse Biosciences, we are committed 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.

LOCAL CANDIDATES ONLY

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.