Senior Design Quality Engineer - Medical Devices & Risk

Hinge Health; San Francisco (CA); Hybrid; USD 156,000 - 215,000; Full time

Benefits offered by this job

Dog-friendly office

401(k) match

Learning stipend

Stock purchase plan

Job summary

Hinge Health is seeking a Sr Design Quality Engineer for its Hardware organization in San Francisco. You will guide design quality from concept through commercialization, partnering across engineering, product, manufacturing, and regulatory affairs to ensure patient safety and compliance.

The role emphasizes design controls, risk management, verification/validation, and process validation, with a hybrid work model requiring in‑person attendance three days per week at the SF office.

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.

Responsibilities

• 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.
• Help teams 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.

Skills

Quality engineering

Regulatory knowledge

Risk management

Design controls

Cross-functional collaboration

Education

Advanced degree in engineering, mathematics, physics, or a related technical field

Job description

Hinge Health is seeking a Sr Design Quality Engineer for its Hardware organization in San Francisco. You will guide design quality from concept through commercialization, partnering across engineering, product, manufacturing, and regulatory affairs to ensure patient safety and compliance.

The role emphasizes design controls, risk management, verification/validation, and process validation, with a hybrid work model requiring in‑person attendance three days per week at the SF office.