Senior Design Quality Engineer

Hinge Health • San Francisco, CA

3d • Hybrid

About The Position

Join Hinge Health’s Hardware organization to build safe, reliable, scalable healthcare products that help people move beyond pain. The Senior Design Quality Engineer is a core member of cross-functional product development teams, guiding design quality from early concept through commercialization and design transfer. The role applies expertise in design controls, risk management, verification and validation, reliability, manufacturability, product development lifecycle activities, and process validation. It partners with engineering, product, manufacturing, purchasing, test, supplier engineering, and Regulatory Affairs to support efficient development while maintaining patient safety, product quality, and compliance.

In the first three months, the engineer will develop working knowledge of Hinge Health’s quality management system, product development lifecycle, tools, and design-quality practices; establish partnerships across relevant teams; and review active program requirements, design records, risk documentation, and development plans for quality and compliance gaps. Within six months, the role will own or materially contribute to design-control and risk-management execution, maintain inspection-ready design history file records, develop and review risk-based verification and validation strategies, and provide quality feedback on designs and requirements. Within a year, the engineer will drive quality readiness for design transfer and commercialization, support risk management and Regulatory Affairs activities, coach engineering teams, and improve quality workflows and cross-functional practices.

This is a hybrid role based in Hinge Health’s San Francisco office, with in-person attendance three days per week for the full eight hours of a typical business day. The office has a dog-friendly workplace program.

Requirements

• Bachelor’s degree in electrical engineering, mechanical engineering, systems engineering, mathematics, physics, or a related technical field.
• At least 6 years of experience in quality engineering or a related field, including at least 4 years in a medical-device design and development environment.
• At least 3 years of experience applying design controls and risk management from early design and development through commercialization.
• Experience with electromechanical systems and applicable medical-device standards, such as ISO 13485, ISO 14971, IEC 60601, IEC 62304, and 21 CFR Part 820.

Nice To Haves

• Advanced degree in engineering, mathematics, physics, or a related technical field.
• Experience with software as a medical device (SaMD) and software in a medical device (SiMD).
• Experience navigating a quality management system with minimal oversight across individual product development projects.
• Ability to make balanced risk decisions, build consensus, and work through complex technical challenges.
• Experience coaching, mentoring, or teaching engineering teams in design quality, data analysis, protocol development, reliability, or design-for-quality methods.
• Experience communicating complex quality, technical, and regulatory information to executive management.

Responsibilities

• Build knowledge of the quality management system, product development lifecycle, tools, and design-quality practices.
• Establish partnerships with hardware, software, systems, product, program management, and Regulatory Affairs stakeholders.
• Review product requirements, design records, risk documentation, and development plans for quality and compliance gaps.
• Own or contribute to design-control and risk-management activities throughout product development, from user needs and design inputs through design outputs, verification, validation, and transfer.
• Create and maintain complete, accurate, traceable, and inspection-ready design history file records.
• Develop and review risk-based verification and validation strategies, including protocols, reports, acceptance criteria, traceability, and objective evidence.
• Provide actionable quality feedback on design architectures, component selections, requirements, drawings, interfaces, usability and human-factors considerations, and risk controls.
• Drive quality readiness for design transfer and commercialization in partnership with manufacturing, purchasing, test, and supplier engineering.
• Support scalable designs, process validation, production readiness, and configuration control.
• Lead or support product risk-management activities covering user, design, process, supplier, and software-enabled product risks.
• Support Regulatory Affairs with submissions, regulatory-question responses, and audit preparation, participation, response development, and follow-up.
• Coach and influence engineering teams on design quality, design controls, risk management, data analysis, protocol development, reliability, and design-for-quality methods.
• Identify and implement practical improvements to quality workflows, templates, instructions, and cross-functional practices.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Support for employees and family members with gender-affirming care, family and fertility planning tools, and travel reimbursements when healthcare is unavailable locally.
• Traditional or Roth 401(k) retirement plan options with a 2% company match.
• Modern life stipends to support learning and development.
• Discounted company stock through an employee stock purchase plan (ESPP).
• Dog-friendly San Francisco office.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior