Senior Design Quality Engineer

Hinge Health

. Guide design quality from early concept through commercialization and design transfer .

Posted 10/23/2026full-timeSan Francisco • California • United StatesSenior💰 $156,000 - $214,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality engineering within medical-device design and development, focusing on design controls, risk management, and compliance with industry standards. Proficient in guiding cross-functional teams through quality workflows and regulatory submissions while ensuring product readiness for commercialization.

Highest-signal resume keywords

Quality Engineering ExperienceDesign Controls ExpertiseRisk Management ProficiencyMedical-Device Standards KnowledgeCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Design ControlRisk ManagementQuality Management SystemVerification and ValidationElectromechanical SystemsISO 13485ISO 14971IEC 60601IEC 6230421 CFR Part 820

Soft Skills

CoachingMentoringConsensus BuildingComplex Problem SolvingCommunication

Industry Keywords

Medical DeviceDesign TransferCommercializationRegulatory AffairsQuality Workflows

About the role

Key responsibilities & impact

Guide design quality from early concept through commercialization and design transfer
Partner with engineering, product, manufacturing, purchasing, test, supplier engineering, and Regulatory Affairs
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 across product development programs
Create and maintain complete, accurate, traceable, inspection-ready design history file records
Develop and review risk-based verification and validation strategies, protocols, reports, acceptance criteria, traceability, and objective evidence
Provide quality feedback on design architectures, component selections, requirements, drawings, interfaces, usability, human factors, and risk controls
Drive quality readiness for design transfer and commercialization, including scalable designs, process validation, production readiness, and configuration control
Lead or support product risk-management activities across user, design, process, supplier, and software-enabled product risks
Support Regulatory Affairs with submissions, regulatory responses, 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
Improve quality workflows, templates, instructions, and cross-functional ways of working

Requirements

What you’ll need

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
At least 4 years in a medical-device design and development environment
3+ years applying design controls and risk management from early design and development through commercialization
Experience with electromechanical systems
Knowledge of applicable medical-device standards including ISO 13485, ISO 14971, IEC 60601, IEC 62304, and 21 CFR Part 820
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
Ability to make balanced risk decisions, build consensus, and work through complex technical challenges
Experience coaching, mentoring, or teaching engineering teams
Experience communicating complex quality, technical, and regulatory information to executive management
Willingness to work from the San Francisco office three days per week for the full 8-hour business day
Located in or willing to relocate to the San Francisco Bay Area
Legally authorized to work in the United States

Benefits

Comp & perks

Comprehensive medical, dental, and vision coverage
Gender-affirming care support
Family and fertility planning tools
Travel reimbursements if healthcare isn’t available where you live
Traditional or Roth 401(k) retirement plan options
2% company 401(k) match
Learning and development stipend
Discounted company stock through ESPP
Dog-friendly workplace program