Principal 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.