Senior Design Quality Engineer

Hinge Health • San Francisco, CA

1d • $156,000 - $214,500 • Hybrid

About The Position

Join Hinge Health’s Hardware organization to help build safe, reliable, scalable healthcare products. As a core member of cross-functional product development teams, the Senior Design Quality Engineer guides 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 timely development while protecting patient safety, product quality, and compliance.

During the first three months, the engineer builds working knowledge of Hinge Health’s quality management system, product development lifecycle, tools, and design-quality practices; establishes stakeholder partnerships; and begins reviewing requirements, design records, risk documentation, and development plans for quality and compliance gaps. Within six months, the engineer owns or materially contributes to design-control and risk-management execution, supports complete and traceable design history files, develops and reviews risk-based verification and validation strategies, and provides quality feedback on designs and related considerations. Within the first year, the engineer drives quality readiness for design transfer and commercialization, supports risk-management and regulatory activities, coaches engineering teams, and improves quality workflows and cross-functional practices.

This is a hybrid role based in Hinge Health’s San Francisco office, with in-person attendance required 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.
• 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 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.
• Ability to guide cross-functional teams through complex, regulated product development and commercialization activities.
• Ability to make risk-based decisions that protect patient safety and product quality while balancing schedule, cost, technical, and business constraints.
• Ability to solve complex problems with minimal oversight, follow issues through resolution, and escalate risks affecting safety, compliance, or launch readiness.
• Clear communication skills to explain complex technical, quality, and regulatory information to engineers, cross-functional partners, and executive stakeholders.
• Collaborative coaching approach that helps teams adopt practical design-quality practices.
• Curiosity about evolving medical-device standards, software-enabled products, reliability methods, and ways to scale quality.

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.
• Demonstrated 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 working knowledge of the quality management system, product development lifecycle, tools, and design-quality practices.
• Establish trusted partnerships with hardware, software, systems, product, program management, and Regulatory Affairs stakeholders.
• Review requirements, design records, risk documentation, and development plans for quality and compliance gaps.
• Own or materially contribute to design-control and risk-management execution from user needs and design inputs through design outputs, verification, validation, and transfer.
• Help 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, including 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, responses to regulatory questions, 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 ways of working.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Help with gender-affirming care for employees and family members.
• Tools for family and fertility planning.
• Travel reimbursements if healthcare is not available where the employee lives.
• Traditional or Roth 401(k) retirement plan options with a 2% company match.
• Learning and development stipend.
• Discounted company stock through an employee stock purchase plan (ESPP) with payroll deductions.

What This Job Offers

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