Engineer, Design Assurance

Our client, a leading organization in the medical device industry, is seeking an Engineer, Design Assurance to join their team. As an Engineer, Design Assurance, you will be part of the Quality Systems Department supporting Risk Management and Product Development teams. The ideal candidate will demonstrate strong analytical skills, effective communication, and a proactive approach, which will align successfully in the organization.

Title: Design Assurance Engineer
Location: Pleasanton, CA
Duration: 6 Month
Shift: 6AM - 2:30PM
100% On-Site

What's the Job?

• 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.

What's Needed?

• Bachelor’s Degree in Engineering or a Technical Field with 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.

What's in it for me?

• Opportunity to work in a dynamic and innovative environment focused on improving healthcare products.
• Engage in meaningful projects that impact patient safety and product quality.
• Collaborate with a diverse team of professionals committed to excellence.
• Develop your expertise in risk management and quality assurance within the medical device industry.
• Be part of a company that values continuous learning and professional growth.

Consultants Eligible Benefits Upon 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)

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!