Senior Design Quality Engineer - Medical Devices(Hybrid SF)

Alt; San Francisco (CA); Hybride; USD 140 000 - 190 000; Plein temps

Avantages offerts par ce poste

Inclusive healthcare and benefits

2% company match (401(k)

Modern learning stipends

Employee stock purchase plan (ESPP)

Résumé du poste

Hinge Health’s Hardware organization seeks a Sr Design Quality Engineer to guide design quality from concept to transfer, ensuring patient safety and regulatory compliance. You’ll collaborate with engineering, manufacturing, and Regulatory Affairs to implement robust quality systems.

Responsibilities cover risk management, design-controls execution, verification/validation, and design-history records across electromechanical products. Hybrid SF-based role.

Qualifications

• Bachelor's degree in a technical field (EE, ME, systems, physics, etc.).
• 6+ years in quality engineering with 4+ years in medical-device design and development.
• 3+ years applying design controls and risk management across design stages.

Responsabilités

• Lead design-quality activities from concept through transfer and commercialization.
• Develop risk-based verification/validation strategies with clear acceptance criteria.
• Collaborate with manufacturing, supplier engineering, and Regulatory Affairs to ensure compliance.
• Coach teams on design quality, reliability, and process validation.

Connaissances

Quality engineering expertise

Design controls

Risk management

Regulatory familiarity

Cross-functional collaboration

Formation

Bachelors in engineering or related field

Outils

Design history file

ISO 13485/14971 knowledge

FDA/IEC standards

Description du poste

Hinge Health’s Hardware organization seeks a Sr Design Quality Engineer to guide design quality from concept to transfer, ensuring patient safety and regulatory compliance. You’ll collaborate with engineering, manufacturing, and Regulatory Affairs to implement robust quality systems.

Responsibilities cover risk management, design-controls execution, verification/validation, and design-history records across electromechanical products. Hybrid SF-based role.