Design Quality Lead

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

• Set the direction for and champion design quality within R&D, working side by side with engineering on the design and development of the product.
• Own the implementation and management of design controls across the development lifecycle, in line with ISO 13485, 21 CFR 820 / QMSR, and ISO 14971.
• Build and maintain Design History Files (DHFs) and the associated design documentation.
• Own document control for the design and development space.
• Drive design verification and validation (V&V) testing, including planning, protocol development, execution support, and reporting.
• Lead design-phase risk management to ISO 14971, including hazard analysis, FMEAs, and risk documentation.
• Embed human factors and usability engineering (IEC 62366) into the design process, with particular attention to the device's user-selected setting.
• Apply software quality practices (IEC 62304) to the device's onboard software across the development lifecycle.
• Partner with external design and manufacturing partners, and bring their design records under the company's design controls.
• Lead design reviews and ensure design outputs trace cleanly to inputs and requirements.
• Partner with the broader Quality function to make sure design-phase practices align with the wider QMS and future regulatory needs.

Requirements

• Medical device experience (required). Candidates without a medical device background will not be a fit for this role.
• Strong, hands-on design quality experience, including design controls within a regulated device environment.
• A track record of leading design quality across a device development program, with the seniority to influence engineering and R&D leadership.
• Deep working knowledge of ISO 13485, 21 CFR 820 / QMSR, and ISO 14971.
• Direct experience building and maintaining DHFs and design documentation.
• Experience with design verification and validation testing.
• Solid design-phase risk management experience, including FMEAs and hazard analysis.
• Experience applying human factors / usability engineering (IEC 62366) and software lifecycle standards (IEC 62304).
• A technical mindset and the credibility to be the quality partner engineers actually want in the room.
• Comfort working hands-on in an early-stage, fast-moving development environment.

Preferred

• Combination device and / or complex Class III electromechanical device experience.
• Experience managing design records across external design and manufacturing partners.
• Experience taking a novel or first-of-its-kind device through design and development.
• Exposure to biologics-adjacent or biological handling contexts.