Hinge Health · 2 days ago
Senior Design Quality Engineer
San Francisco, CA
Full-time
Hybrid
Mid, Senior Level
$120K/yr - $180K/yr
4+ years expHinge Health is a company that leverages software, including AI, to automate care for joint and muscle health. The Sr Design Quality Engineer will support product development from concept through commercialization, ensuring that products meet quality standards and comply with regulatory requirements.
Health CareMedicalTherapeutics
Responsibilities
Planning and execution of design controls, risk management, and design verification/validation for new products
Advocate product design history file and ensure compliance to internal processes and external standards and regulations
Understand user needs and assure they are translated to the design, while ensuring compliance to usability and human factors standards and regulations
Partner with engineering to define design inputs, design outputs, and traceability matrices
Contribute to the strategy and execution of risk-based design verification and validation
Accountable for overall risk management file: participate and support the development of product risk management file, to analyze and assess the product risks associated with user, design, process and supplier
Review and provide feedback on design architectures, selections, requirements, and drawings from early design
Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of scalable designs into production
Contribute to new product development Technical Reviews and Design Reviews
Support Regulatory Affairs with creating submissions and responding to submission questions
Perform and/or support audits (internal, external, and by regulatory agencies)
Coach, mentor, teach, and influence the engineering staff in best quality practices, data analysis, protocol development, and design for quality and reliability methods
Qualification
Required
Bachelor's degree in electrical, mechanical or system engineering, math, or physics
4+ years of working experience in Quality Engineering or related field, minimum 3 years in medical device design environment
2+ years of working experience in design control and risk management from early design and development through commercialization
Demonstrated experience with electromechanical systems
Experience with medical standards compliance, including ISO 13485, ISO 14971, IEC 60601, IEC 62304, and 21 CFR 820 with a focus on design controls and risk management
Preferred
Experience with SaMD and SiMD is preferred
Able to navigate the quality system with minimal oversight on individual projects
Balanced risk decision making to drive product quality, gain consensus, and work through technical challenges
Solves complex problems with minimal oversight
Able to articulate complex information to teams, including executive management
Benefits
Comprehensive medical, dental, and vision coverage
Help with gender-affirming care
Tools for family and fertility planning
Travel reimbursements if healthcare isn’t available where you live
Traditional or Roth 401k retirement plan options which include a 2% company match
Modern life stipends
Company
Hinge Health
Hinge Health is a digital clinic for joint, and muscle care, pelvic pain, bowel, and bladder control.
1001-5000 employees
H1B Sponsorship
Hinge Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (18)
2023 (9)
2022 (17)
2021 (13)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$1.03BKey Investors
Bessemer Venture PartnersInsight PartnersAtomico
2025-05-22IPO
2021-10-28Series E· $400M
2021-10-28Secondary Market· $200M
Leadership Team
Daniel Perez
Co-Founder, CEO
Gabriel Mecklenburg
Co-founder, Executive Chairman
Recent News
2025-12-24
2025-11-24
2025-11-19
Company data provided by crunchbase