Hinge Health
Senior Design Quality Engineer
San Francisco-HQ · Hybrid · Senior · Full-time · Posted Oct 23, 2026
- Experience
- 6+ years in quality engineering or a related field, including at least 4 years in medical-device design and development; 3+ years applying design controls and risk management.
- Education
- Bachelor’s degree in a stated technical field or a related technical field.
About the job
Guides design quality across medical-device product development, from early design through verification, validation, design transfer, and commercialization.
What you'll do
- Own or contribute to design controls, risk management, and inspection-ready design history files across product programs.
- Develop and review risk-based verification and validation strategies, including protocols, reports, acceptance criteria, traceability, and evidence.
- Drive quality readiness for design transfer and commercialization; support regulatory submissions, audits, and quality-process improvements.
What they ask for
- Bachelor’s degree in electrical engineering, mechanical engineering, systems engineering, mathematics, physics, or a related technical field.
- 6+ years of experience in quality engineering or a related field, including at least 4 years in a medical-device design and development environment.
- 3+ years applying design controls and risk management from early design through commercialization.
- Experience with electromechanical systems and applicable standards, including ISO 13485, ISO 14971, IEC 60601, IEC 62304, and 21 CFR Part 820.
Nice to have
- Advanced degree in engineering, mathematics, physics, or a related technical field.
- Experience with SaMD or SiMD, quality management systems, or coaching engineering teams in design quality.
Pay
$156K – $214.5K (base salary)
Tools
ISO 13485, ISO 14971, IEC 60601, IEC 62304, 21 CFR Part 820
Model-written summary · the original posting is authoritative