Principal Quality Engineer

The role

The Principal Quality Engineer will implement and maintain quality systems and qualification activities for the CellFX System and medical devices. This role provides expertise in design assurance, risk management, and compliance to support research, manufacturing, and clinical efforts.

What you will do

• 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
• Lead the risk management process including plan establishment, evaluation, analysis, and reporting
• Lead the process in establishing product traceability matrices and conducting requirement trace verification
• Manage all aspects of biocompatibility testing and sterilization
• Identify and implement effective process control systems
• Develop and validate measurement methods and perform statistical analysis
• Lead the review of process and product quality performance
• Assist with development protocols for design verification and validation
• Design and implement methods for inspecting, testing, and evaluating components and assemblies

Required qualifications

• 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
• Extensive work experience with FDA QSR (21 CFR Part 820 & Part 11) and ISO 13485/MDR requirements
• Extensive knowledge and experience in Risk Assessment (ISO 14971) practices and implementation
• Knowledge and experience in ISO 10993 standard series (Biocompatibility)
• Knowledge and experience in AAMI/ISO 11135 & 11137 (EO & Irradiation sterilization)
• Knowledge and experience in ISO 11607 & ASTM D4169 (Sterile Packaging & Performance Testing)
• Hands-on experience with catheter-based devices from development through commercialization
• Working knowledge and experience in Design Control
• Working knowledge and experience in Design & Process Validation
• Working knowledge and experience in Risk Management
• Working knowledge and experience in Traceability Matrix

Nice to have

• Cardiovascular device experience

Benefits

• A variety of health insurance plans
• Supplemental insurance options
• 401k retirement savings plan
• Stock options awards
• Employee Stock Purchase Plan (ESPP)
• Paid time off
• Paid holidays
• Flexible work schedule
• Wellness program
• Onsite gym
• Mindfulness classes

Before you apply

• Candidates must reside in the San Francisco Bay Area
• No relocation offered

About the company

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation. The Company’s proprietary CellFX® nsPFA™ technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells.