Principal Quality Engineer

pulsebiosciences; Hayward (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Pulse Biosciences in Hayward, CA is seeking a Principal Quality Engineer to lead quality systems for CellFX medical devices, ensuring compliance with 21 CFR 820 and ISO 13485.

You will guide design controls, risk management, biocompatibility testing, sterilization, and regulatory submissions, collaborating with R&D, manufacturing, and regulatory affairs.

Bachelor's in engineering or related field required; medical device quality leadership preferred; strong analytical and communication skills.

Qualifications

• Bachelor's degree in Engineering, Science or related technical field.
• Experience implementing QSR (21 CFR 820) and ISO 13485 requirements.
• Strong knowledge of design controls and risk management practices.

Responsibilities

• Provide expertise in design assurance and compliance for product development and manufacturing.
• Develop and maintain quality engineering methodologies meeting regulatory requirements.
• Lead risk management planning, evaluation and reporting.
• Establish traceability matrices and conduct requirement verification.
• Oversee biocompatibility testing and sterilization activities.
• Support regulatory audits and assist with submissions.

Skills

Design assurance

Design controls

Regulatory compliance

Risk management

Traceability

Biocompatibility testing

Sterilization

Statistical analysis

Quality systems

Education

Bachelor's degree in Engineering or related field

Tools

Quality management systems

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 experien