About the RoleThe 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, surgical 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.
To Make an Impact, You Will:- 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.
- Lead the risk management process in establishing risk management plan, conducting risk evaluation and analysis, and creating risk management report.
- Lead the process in establishing product traceability matrices, conducting requirement trace verification and analysis, and creating trace matrix reports.
- Manage all aspects of biocompatibility testing and sterilization including creating of test protocols and executing of testing.
- Proactively investigate, identify, and implement best-in-class quality engineering practices.
- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
- Develop and validate measurement methods, monitor design control standards, facilitate, and perform statistical analysis, and participate in MRB as appropriate.
- Lead the review of process and product quality performance, working in concert with various departments.
- Assist with development protocols for design verification and validation in conjunction with R&D
- Design and implement methods and procedures for inspecting, testing, and evaluating components, sub-assemblies, and final assemblies.
- Support management review activities, regulatory audits including Notified Body audit (MDSAP) and assist with preparation of regulatory submissions.
- 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.
To Excel, You Will Bring:- Bachelor's degree in Engineering, Science, related technical/life science field or equivalent experience.
- 10+ years working as a Quality Engineer within a Class III/II medical device industry. Cardiovascular device experience is preferred.
- Must have extensive work experience with FDA QSR (21 CFR Part 820 & Part 11) and ISO 13485/MDR 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).
- Hands-on experience with catheter-based devices from development through commercialization.
- 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
- Traceability Matrix
- Biocompatibility
- Sterilization Validation
- Packaging Validation
- Statistical Analysis
- Quality System Compliance
- Complaint handling
- CAPA management
- 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.
Pay Range:Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $145k-$180k. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.
Ready to Shape the Future of Healthcare?Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation. To learn more about us, visit our website at www.pulsebiosciences.com.
