Design Verification Engineer

Qualitest Group

$100K — $120K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • 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 own deliverables such as protocols, reports, and logs.
  • Supervise and mentor junior engineers during test execution and troubleshooting.
  • Collaborate with cross-functional teams to ensure verifiable design inputs meet FDA requirements.
  • Develop and validate new test methods and fixtures.
  • Perform statistical analyses and ensure adequate sample size for verification activities.
  • Conduct detailed investigations into anomalies, defects, and failures, ensuring timely resolution.

Benefits

  • Support for diversity and inclusion in the workplace, celebrating culture and knowledge-sharing.
  • Opportunities for local and global career growth through internal rotations and international mobility.
  • Clear career progression pathway in a rapidly growing company.
  • Flexible and casual work culture with employee events and amenities.
  • Extensive learning opportunities with 3000+ training courses, mentorship, and leadership programs.
  • Referral bonus programs for client and employee referrals.
Full Job Description
We are looking for a Design Verification Engineer to join our growing team in Fremont, CA United States!

Essential Functions:
  • 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.


Competencies:
  • 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.


Benefits:

  • Be a part of a company who strives to support for diversity and inclusion in the workplace - we are one, we are many at QualityAI. Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences.
  • Local and global opportunities - we offer you internal rotation and international mobility opportunities to grow your career.
  • Clear view of your career and progression with the company - QualityAI is growing massively (since Jan 2021 - added more than 2000 engineers) and giving you the opportunity to grow with us.
  • Work hard and play harder with our flexible and casual culture. Take a break from work and join an employee event, or enjoy the amenities and games provided from one of our Employees Centers.
  • Never stop experimenting and learning with QualityAI Tech academy: 3000+ training courses, mentorship programs, technical tribes, sponsored certifications, leadership programs and much more.
  • Earn bonuses via our Client Referral and Employee Referral Program's. Refer and earn - tap your network for net-worth.
  • A Competitive pay, the salary range for the role is $100,000 - $120,000.


If you like what you have read, send us your resume and let's start talking!
Intrigued to find more about us?
Visit our website at https://www.QualityAIgroup.com/
If you like what you have read, send us your resume and let's start talking!
LinkedIn: https://www.linkedin.com/company/qualityaigroup

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