Design Verification Engineer

Qualitest GroupSanta Clara, CA
$120,000 - $120,000Onsite

About The Position

We are looking for a Design Verification Engineer to join our growing team in Fremont, California! This role involves leading verification activities, collaborating with cross-functional teams, and ensuring designs meet regulatory requirements. The ideal candidate will have a strong background in medical device verification and statistical analysis.

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
  • 3000+ training courses
  • Mentorship programs
  • Technical tribes
  • Sponsored certifications
  • Leadership programs
  • Corporate Wellness Program (gym membership reimbursement, earn additional vacation time)
  • Client Referral and Employee Referral Program bonuses
  • Employee Perks for discounts on travel, electronics, etc.
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