Engineer, Design Assurance

Experis; Pleasanton (CA); On-site; USD 110,000 - 145,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Vision Plan

Health Savings Account

Flexible Spending Accounts

401(k)

Job summary

Experis is seeking an Engineer, Design Assurance in Pleasanton, CA for a 6-month on-site assignment in the medical device industry. You will support Risk Management and Product Development within the Quality Systems Department, focusing on ISO 14971 guidelines and design verification activities.

The role requires a Bachelor’s in Engineering with at least 5 years of experience, strong communication, cross-functional collaboration, and proficiency with risk management documentation.

Qualifications

• Bachelor’s Degree in Engineering or a technical field; 5+ years of relevant experience.
• Regulated environment experience, preferred medical devices, with ISO 14971 knowledge.
• Strong understanding of design verification, validation, and risk management documentation.

Responsibilities

• Lead design assurance activities supporting risk management files per ISO 14971.
• Develop risk management files including Hazard Analysis, FMEA, and Risk Management Reports.
• Collaborate with Engineering, Marketing, Manufacturing, and Regulatory teams to establish risk documentation.
• Review test plans, procedures, and reports related to risk controls and design verification.
• Participate in design validation and verification activities aligned with risk management strategies.

Skills

Analytical thinking

Communication

Cross-functional collaboration

Education

Bachelor’s degree in Engineering or technical field

Job description

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
• 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)