Engineer, Design Assurance

Location: Pleasanton, CA • Duration: 6 Month • Shift: 6AM - 2:30PM • 100% On-Site

About the role

Responsible for implementing and maintaining Risk Management processes within the Quality System. Provide quality engineering support for new product development, manufacturing, and post-market activities. Serve as the Subject Matter Expert (SME) for Risk Management and ensure compliance with GMP, ISO, and regulatory requirements. Collaborate with cross-functional teams to establish and maintain product risk documentation.

Responsibilities

• Lead Risk Management activities and documentation in accordance with ISO 14971.
• Develop and maintain Hazard Analysis, FMEA, Risk Management Plans, Risk Management Reports, and Benefit-Risk Analyses.
• Manage new and existing Risk Management Files.
• Work with Engineering, Manufacturing, Quality, Regulatory, Clinical, and Marketing teams on product risk assessments.
• Support design verification and validation activities related to risk controls.
• Review test plans, protocols, procedures, and reports supporting risk mitigation.
• Perform Health Hazard Evaluations and Regulatory Risk Evaluations.
• Lead technical discussions related to product risks and risk documentation.
• Mentor and train teams on Risk Management requirements and best practices.

Requirements

• Minimum 5 years of experience in Design Assurance, Quality Engineering, or Risk Management.
• Strong knowledge of ISO 14971 and medical device risk management principles.
• Experience working in a cross-functional and matrixed environment.
• Strong communication, analytical, organizational, and problem-solving skills.
• Ability to manage multiple priorities and meet deadlines.
• Advanced computer, data analysis, and report-writing skills.
• Bachelor's Degree in Engineering or Technical Field.

Preferred Qualifications

• Medical device industry experience.
• Knowledge of Risk Management tools and methodologies.
• Knowledge of IEC 60601-1 and electrical safety requirements.

Benefits

Available upon waiting period for eligible consultants:

• 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)