Engineer, Design Assurance

Location: Pleasanton, CA 94588
Duration: 6-month contract (with possible extension)
Schedule: Mon–Fri, 6:00 AM – 2:30 PM, onsite

About the role

Seeking a Design Assurance Engineer / Risk Management Subject-Matter Expert to support quality systems and Risk Management activities within new product development, manufacturing, and post-market support.

Responsibilities

• Lead Design Assurance activities for Risk Management Files including Hazard Analysis, FMEA, Risk Management Plans/Reports, and Benefit-Risk Analysis per ISO 14971.
• Manage new Risk Management Files and maintain existing documentation.
• Partner with Engineering, Marketing, Manufacturing, Regulatory, Clinical, and Quality teams.
• Support risk controls through understanding of test plans, procedures, and reports.
• Link Design Verification (DV) and Design Validation (PV) activities to Risk Management Files.
• Evaluate Risk Management implications for Verification and Validation sampling plans.
• Lead technical discussions related to product risks and Risk Management documentation.
• Interpret regulations and requirements and mentor/train development and sustaining engineering teams.

Requirements

• Bachelor’s Degree in Engineering or Technical Field.
• Medical Device experience preferred.
• Risk Management experience with ISO 14971 required.
• Strong knowledge of Risk Management tools and techniques.
• IEC 60601-1 / electrical safety knowledge desirable.
• Strong communication, organizational, analytical, and technical documentation skills.
• Experience working in a highly matrixed and geographically diverse environment.