Job Details

We're seeking a Senior Design Quality Engineer to support product design, development, and manufacturing of electronic and electromechanical medical devices. This role ensures compliance with QMS, ISO, and FDA regulations while driving quality across development and commercial operations.

Overview

The successful candidate will lead quality efforts on cross-functional project teams for new and existing products, support design control, risk management, and product verification/validation, develop and validate test methods, inspection procedures, and quality standards, analyze non-conformances, lead investigations, and support CAPA/NCR boards, prepare documentation and support audits (FDA, FDB, notified body), provide training, guidance, and mentorship to team members, and collaborate with contract manufacturers on electromechanical devices and PCBAs.

Key Responsibilities

• Lead quality efforts on cross-functional project teams for new and existing products
• Support design control, risk management, and product verification/validation
• Develop and validate test methods, inspection procedures, and quality standards
• Analyze non-conformances, lead investigations, and support CAPA/NCR boards
• Prepare documentation and support audits (FDA, FDB, notified body)
• Provide training, guidance, and mentorship to team members
• Collaborate with contract manufacturers on electromechanical devices and PCBAs

Qualifications

• Bachelor's degree in Engineering, Life Science, or related field (advanced degree preferred)
• 5+ years of quality assurance experience in medical devices or regulated industry
• Hands-on experience with PFMEA, NCRs, CAPAs, change control, and failure investigations
• Familiarity with electronics/PCBA manufacturing and contract manufacturing
• Background in auditing, sterilization, design reviews, and/or project management

Working Conditions

• Mix of office, lab, and cleanroom environments
• Limited travel (0–10%)
• Ability to lift up to 25 lbs and support inspections, audits, and hands-on testing

Compensation: $150,000 – $170,000

Location: SF Bay Area