Job Details

Staff Design Quality Engineer – Class III Implantable Medical Device

San Francisco Bay Area | Full-Time | Hybrid

A fast-growing medical device company developing next generation implantable technology is expanding its engineering team and hiring a Staff Design Quality Engineer to support the development of a highly innovative Class III medical device platform.

This is a highly technical, hands-on role embedded directly with R&D, focused on ensuring quality is built into product development from early feasibility through clinical and commercial stages.

You will play a key role in helping bring a breakthrough therapy to market while working alongside experienced engineers and cross-functional leaders in a collaborative development environment.

Responsibilities

• Partner closely with R&D and systems engineering teams to integrate design quality into product development
• Lead and support design control activities throughout the product lifecycle
• Drive risk management efforts (ISO 14971) including hazard analysis, FMEAs, and risk mitigation strategies
• Support verification and validation planning and execution
• Ensure compliance with FDA design control requirements and global quality standards
• Participate in cross-functional design reviews and technical decision making
• Help translate regulatory and quality requirements into practical engineering processes

Qualifications

• BS or MS in Engineering (Biomedical, Mechanical, Electrical, or related)
• 7+ years of experience in medical device product development or design quality
• Strong experience with design controls and risk management
• Experience supporting Class II or Class III medical devices
• Ability to collaborate closely with R&D in early-stage product development
• Experience supporting IDE, PMA, or complex regulatory pathways is highly valued

What Makes This Opportunity Unique

• Work on cutting-edge implantable technology
• Join a highly technical engineering-driven team
• Be involved early in the development lifecycle
• Significant opportunity for technical ownership and influence
• Competitive compensation, bonus, and equity package

If you are interested in learning more, feel free to reach out directly.