Design Verification Engineer

Qualitest Group • Santa Clara, CA

7d • $100,000 - $120,000 • Onsite

About The Position

We are looking for a Design Verification Engineer to join our growing team in Fremont, CA United States! This role involves leading verification activities, mentoring junior engineers, collaborating with cross-functional teams to ensure design inputs meet FDA requirements, developing and validating new test methods, performing statistical analyses, and conducting investigations into anomalies, defects, and failures.

Requirements

• 8+ years of experience in design verification for medical devices.
• Expertise in statistical methods and advanced data analysis.
• Demonstrated leadership skills and experience supervising technical teams.
• Deep understanding of IEC 60601-1, IEC 62304, and other relevant standards.

Responsibilities

• Lead verification activities and take ownership of deliverables, including protocols, reports, and logs.
• Supervise and mentor junior engineers in test execution, troubleshooting, and documentation.
• Collaborate with cross-functional teams to ensure design inputs are verifiable and meet FDA requirements.
• Develop and validate new test methods and fixtures.
• Perform statistical analyses and ensure proper sample size calculations for all verification activities.
• Conduct detailed investigations into anomalies, defects, and failures, ensuring timely resolution.

Benefits

• 401k plan with company match
• Competitive healthcare benefits
• HSA match
• Learning & Development platform (QCraft)
• Corporate Wellness Program (Gym membership reimbursement, additional vacation time for gym attendance)
• Client Referral and Employee Referral Program bonuses
• Qudos platform for bonuses and spot awards
• Employee Perks for discounts
• Competitive pay

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed