Principal Quality Engineer

Pulse Biosciences•Hayward, CA

2d•Onsite

About The Position

The Principal Quality Engineer will participate in implementing and maintaining QSR (21 CFR 820) and ISO 13485 quality systems, and qualification activities for the CellFX System and surgical disposable and reusable medical devices. The role supports the Company’s research and development, manufacturing, regulatory, and clinical affairs efforts, as well as development and implementation of quality systems and compliance activities. This position provides quality engineering expertise across product development and manufacturing, including design assurance, design controls, risk management, traceability, biocompatibility, sterilization, validation, and quality-system compliance. The role is onsite in Hayward, California, and candidates must reside in the San Francisco Bay Area. No relocation is offered. Travel may be up to 10%, including overnight and/or international travel. The stated Northern California base salary range is $145,000–$180,000.

Requirements

Bachelor’s degree in Engineering, Science, a related technical or life-science field, or equivalent experience.
10+ years of experience as a Quality Engineer in the Class III/II medical device industry.
Extensive experience with FDA QSR (21 CFR Part 820 and Part 11) and ISO 13485/MDR requirements.
Extensive knowledge and experience in risk assessment practices and implementation under ISO 14971.
Knowledge and experience with ISO 10993 biocompatibility standards; AAMI/ISO 11135 and 11137 EO and irradiation sterilization; and ISO 11607 and ASTM D4169 sterile packaging and performance testing.
Hands-on experience with catheter-based devices from development through commercialization.
Mastery of quality disciplines, tools, and methodologies.
Working knowledge and experience in design control; design and process validation; risk management; traceability matrices; biocompatibility; sterilization validation; packaging validation; statistical analysis; quality-system compliance; complaint handling; and CAPA management.
Proficient knowledge and skill in Microsoft Office Suite applications.
Excellent oral and written communication and critical-thinking skills.
Ability to work conscientiously with minimal direction, exercise good judgment and initiative, accomplish short- and long-range projects, and recommend actions with minimal direction.
Ability to work as a team member, multitask, and adapt flexibly to changing priorities and requirements in 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.
Must reside in the San Francisco Bay Area.

Nice To Haves

Cardiovascular device experience is preferred.

Responsibilities

Provide expertise and guidance to product development and manufacturing teams in design assurance, design controls, and compliance.
Develop, establish, and maintain quality engineering methodologies, systems, and practices that meet customer and regulatory requirements.
Lead risk management planning, risk evaluation and analysis, and preparation of risk management reports.
Lead development of product traceability matrices, requirement trace verification and analysis, and trace matrix reports.
Manage biocompatibility testing and sterilization, including creating test protocols and executing testing.
Investigate, identify, and implement quality engineering practices.
Identify and implement process control systems for product development, qualification, and ongoing manufacturing.
Develop and validate measurement methods, monitor design control standards, facilitate and perform statistical analysis, and participate in MRB as appropriate.
Lead reviews of process and product quality performance with other departments.
Assist with development protocols for design verification and validation with R&D.
Design and implement methods and procedures for inspecting, testing, and evaluating components, subassemblies, and final assemblies.
Support management review activities and regulatory audits, including Notified Body audits (MDSAP), and assist with preparation of regulatory submissions.
Carry out responsibilities in accordance with organizational policies and applicable laws.
Support the Pulse Biosciences Quality Policy and Quality System.
Perform other duties as assigned.