Principal Quality Engineer

Pulse Biosciences•Hayward, CA

3d•$145,000 - $180,000•Onsite

About The Position

The Principal Quality Engineer will participate in implementing and maintaining QSR (21 CFR 820) and ISO 13485 quality systems, as well as qualification activities for the CellFX System and surgical disposable and reusable medical devices. The role supports research and development, manufacturing, regulatory, and clinical affairs, and contributes to developing and implementing quality systems and compliance activities. This position is onsite in Hayward, California, and candidates must reside in the San Francisco Bay Area. The role may require travel up to 10% of the time, including overnight and/or international travel. No relocation is offered. The Northern California base salary range is $145,000–$180,000; compensation depends on factors including location, job-related skills, experience, education, and training.

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 work experience with FDA QSR (21 CFR Part 820 and Part 11) and ISO 13485/MDR requirements.
Extensive knowledge and experience in ISO 14971 risk assessment practices and implementation.
Knowledge and experience with the ISO 10993 standard series for biocompatibility; AAMI/ISO 11135 and 11137 for EO and irradiation sterilization; and ISO 11607 and ASTM D4169 for 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 and packaging validation; statistical analysis; quality system compliance; complaint handling; and CAPA management.
Proficiency with 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, evaluation, and analysis, and create risk management reports.
Establish product traceability matrices, conduct requirements trace verification and analysis, and create 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 in coordination with other departments.
Assist with design verification and validation protocol development 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 and regulatory audits, including Notified Body audits (MDSAP), and assist with regulatory submission preparation.
Carry out responsibilities in accordance with organizational policies and applicable laws.
Support the Pulse Biosciences Quality Policy and Quality System, and perform other duties as assigned.