Engineer, Design Assurance

Location: Pleasanton, CA • Duration: 6 months • Shift: 6 AM – 2:30 PM • 100% on-site

About the role

Lead design-assurance activities supporting risk-management files in compliance with ISO 14971 guidelines. Manage and develop new risk-management files, including Hazard Analysis, FMEA, and Risk Management Reports. Collaborate with Engineering, Marketing, Manufacturing, and Regulatory teams to establish comprehensive risk documentation. Review and understand test plans, procedures, and reports related to risk controls and design verification. Participate in design validation and verification activities, ensuring alignment with risk-management strategies.

Requirements

• Bachelor’s degree in Engineering or a technical field
• At least 5 years of relevant experience
• Experience working within a regulated environment, preferably in medical devices, with knowledge of risk management (ISO 14971)
• Strong understanding of design verification, validation, and risk-management documentation
• Excellent verbal and written communication skills, with the ability to work effectively across cross-functional teams
• Proficiency in computer skills, including data analysis, report writing, and familiarity with risk-management tools

Benefits

Consultants are eligible for benefits after a waiting period.

• Medical and prescription-drug plans
• Dental plan
• Vision plan
• Health Savings Account (for high-deductible health plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking, and Commuter Transit)
• Supplemental Life Insurance
• Short-term Disability (coverage varies by state)
• Long-term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)