Principal Quality Engineer

Pulse Biosciences, Inc.; Hayward (CA); On-site; USD 145,000 - 180,000; Full time

Job summary

Pulse Biosciences in Hayward, CA is seeking a Principal Quality Engineer to implement and maintain QSR (21 CFR 820) and ISO 13485 quality systems for CellFX System, surgical disposables, and reusable medical devices. You will lead risk management, traceability, biocompatibility, and sterilization validation efforts across R&D, manufacturing, regulation, and clinical programs.

The role requires 10+ years in medical device QA, extensive FDA QSR/ISO knowledge, and the ability to drive CAPA and

Qualifications

• Bachelor's degree in Engineering or related field required.
• 10+ years in a QA engineering role within a Class III/II medical device environment.
• Experience with FDA QSR and ISO 13485/MDR; ISO 14971 risk management.
• Expertise in design controls, traceability, biocompatibility, and sterilization validation.

Responsibilities

• Provide guidance to product development and manufacturing on design controls and compliance.
• Lead risk management efforts and develop risk management plans and reports.
• Establish and maintain traceability matrices and verification activities.
• Oversee biocompatibility, sterilization, packaging validation, and test protocols.
• Support regulatory audits and submissions; drive quality improvements across teams.

Skills

Design Control

Risk Management

Traceability Matrix

Biocompatibility

Sterilization Validation

Packaging Validation

Statistical Analysis

Quality System Compliance

CAPA management

Project Management

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Office Suite

Job description

Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine

Pulse Biosciences 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 CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.

The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit pulsebiosciences.com to learn more.

Why Join Us?

At Pulse Biosciences, we are driven by purpose and innovation.

• Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards. We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.
• Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.
• Our Commitment: Hiring the best and brightest minds to advance our world-class organization.

What You Will Experience

• Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!
• Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!
• Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!
• Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.
• Ownership and Rewards - Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.
• Work-Life Balance - Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.
• Diversity & Inclusion - A commitment to providing a respectful work environment to our diverse workforce.

About The Role

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, 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?

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.

PRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR THIRD-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS.