Design Quality Lead, Medical Devices & Regulation

Lumicity; San Francisco (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

Lumicity in San Francisco seeks a Design Quality Lead to drive design quality across the full product development lifecycle of medical devices. You will champion design controls, build and maintain DHFs, and guide V&V planning and execution with a hands-on, cross-functional team.

The role requires deep knowledge of ISO 13485, 21 CFR 820 / QMSR, and ISO 14971, plus experience embedding human factors (IEC 62366) and software lifecycle standards (IEC 62304) in a fast-moving environment.

Qualifications

• Medical device experience required.
• Strong, hands-on design quality experience in regulated device environments.
• Lead design quality across a device development program with senior influence.

Responsibilities

• Set direction for design quality and champion quality within R&D and engineering.
• Own design controls across the development lifecycle per ISO 13485, 21 CFR 820 / QMSR, ISO 14971.
• Build and maintain DHFs and design documentation; own document control.
• Lead V&V planning, protocol development, execution support, and reporting.
• Lead design-phase risk management (FMEAs, hazard analysis) per ISO 14971.

Skills

Medical device experience

Design quality leadership

Regulatory awareness

DHFs and design docs

V&V experience

Human factors IEC 62366

Software lifecycle IEC 62304

ISO 13485 knowledge

21 CFR 820 / QMSR knowledge

Education

Biomedical/Mechanical Engineering degree

Job description

Lumicity in San Francisco seeks a Design Quality Lead to drive design quality across the full product development lifecycle of medical devices. You will champion design controls, build and maintain DHFs, and guide V&V planning and execution with a hands-on, cross-functional team.

The role requires deep knowledge of ISO 13485, 21 CFR 820 / QMSR, and ISO 14971, plus experience embedding human factors (IEC 62366) and software lifecycle standards (IEC 62304) in a fast-moving environment.