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Join Hinge Health's Hardware organization as a Senior Design Quality Engineer to help build safe, reliable, scalable healthcare products that improve how people move beyond pain. You'll be a core member of cross-functional product development teams, guiding design quality from early concept through commercialization and design transfer.
In your first three months, you'll build working knowledge of Hinge Health's quality management system, product development lifecycle, tools, and design-quality practices while establishing trusted partnerships with hardware, software, systems, product, program management, and Regulatory Affairs stakeholders.
Within six months, you'll own or materially contribute to design-control and risk-management execution across product development programs, from user needs and design inputs through design outputs, verification, validation, and transfer. You'll help teams create and maintain complete, accurate, traceable, and inspection-ready design history file records. You'll develop and review risk-based verification and validation strategies, including protocols, reports, acceptance criteria, traceability, and objective evidence. You'll provide actionable quality feedback on design architectures, component selections, requirements, drawings, interfaces, usability and human-factors considerations, and risk controls.
By your first year, you'll drive quality readiness for design transfer and commercialization by partnering with manufacturing, purchasing, test, and supplier engineering on scalable designs, process validation, production readiness, and configuration control. You'll lead or support product risk-management activities covering user, design, process, supplier, and software-enabled product risks. You'll support Regulatory Affairs with submissions, responses to regulatory questions, and audit preparation. You'll coach and influence engineering teams on design quality, design controls, risk management, data analysis, protocol development, reliability, and design-for-quality methods. You'll identify and implement practical improvements to quality workflows, templates, instructions, and cross-functional ways of working as Hinge Health scales its medical-device product organization.
You'll bring practical expertise in design controls, risk management, verification and validation, reliability, manufacturability, product development lifecycle activities, and process validation. You'll partner closely with engineering, product, manufacturing, purchasing, test, supplier engineering, and Regulatory Affairs to help teams move quickly without compromising patient safety, product quality, or compliance.
Hinge Health is using technology to scale and automate the delivery of healthcare, starting with musculoskeletal (MSK) conditions, which affect over 1.7 billion people worldwide. The AI-powered human-centered care model leverages cutting-edge technology to improve outcomes, experiences, and costs. The company is the preferred partner to 60+ health plans, PBMs, and other ecosystem partners, available to over 20 million people across more than 2,800 employers. Headquarters in San Francisco with additional offices in Montreal and Bangalore.
This is a hybrid role based in the San Francisco office, requiring in-person attendance three days per week for the full 8 hours of a typical business day. The San Francisco office has a dog-friendly workplace program.
REQUIREMENTS:
Basic Qualifications:
- 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, including experience with electromechanical systems and applicable medical-device standards such as ISO 13485, ISO 14971, IEC 60601, IEC 62304, and 21 CFR Part 820
Preferred Qualifications:
- 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
