Senior Design Quality Engineer

Lumicity; San Francisco (CA); On-site; USD 102,000 - 164,000; Full time

Job summary

A leading company in the medical devices sector is seeking a Design Quality Engineer to ensure product compliance and quality throughout the development lifecycle. The ideal candidate will lead design assurance activities, develop design control processes, and collaborate with teams to integrate quality principles. This role emphasizes regulatory standards and safety in innovative wearable medical technologies.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• Experience in the medical device industry focusing on hardware quality.
• Proven experience with IEC 60601 and familiarity with FDA, ISO 13485.

Responsibilities

• Lead design assurance activities to meet regulatory standards.
• Conduct design verification and validation activities.
• Collaborate with cross-functional teams to integrate quality principles.

Skills

Analytical skills

Problem-solving skills

Communication

Education

Bachelor's degree in Electrical, Mechanical, Biomedical Engineering

Tools

FMEA

Fault tree analysis

Job description

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Hyperspecialized Technical Staffing Consultant | Medtech | Medical Devices | Bay Area, CA

We are looking for a highly experienced and detail-oriented Design Quality Engineer to support the development of innovative wearable medical technologies. In this role, you will ensure product compliance and quality throughout the entire product development lifecycle — from concept through manufacturing and sustaining — with a strong emphasis on regulatory and safety standards.

Key Responsibilities:

• Lead design assurance activities to ensure products meet regulatory and internal quality standards.
• Develop, implement, and maintain design control processes in accordance with international medical device regulations.
• Conduct and document design verification and validation (V&V) activities.
• Review design documentation for compliance with applicable standards and project requirements.
• Apply risk management tools such as FMEA and hazard analysis during all development phases.
• Ensure product safety and reliability through detailed failure analysis and predictive modeling.
• Collaborate with cross-functional teams (engineering, manufacturing, and quality) to integrate quality principles across the development cycle.
• Support audits and inspections by providing well-documented design history and compliance artifacts.
• Interpret and apply standards such as IEC 60601 for electrical safety and performance testing.
• Continuously monitor and integrate feedback related to manufacturability, reliability, and user experience.

Required Qualifications:

• Bachelor's degree in Electrical, Mechanical, Biomedical Engineering, or a related field.
• experience in the medical device industry with a focus on hardware quality and design verification.
• Proven experience with IEC 60601 and familiarity with FDA, ISO 13485, ISO 14971, and MDR requirements.
• Hands-on experience with risk analysis tools including FMEA and fault tree analysis.
• Demonstrated knowledge of the complete product development lifecycle, from concept through sustaining.
• Background in wearable medical devices is highly desirable.
• Strong analytical and problem-solving skills with a data-driven approach.
• Excellent communication and collaboration abilities in cross-functional environments.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Design

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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