Senior Quality Engineer — Medical Devices & Compliance

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 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.