QualiTest Group

Systems V&V Engineer

QualiTest Group$80K — $90K *
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

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

Responsibilities

  • Take ownership of verification deliverables including protocols and reports
  • Collaborate with cross-functional teams to ensure design inputs meet FDA requirements
  • Develop and validate new test methods and fixtures
  • Perform statistical analyses and ensure proper sample size calculations
  • Conduct investigations into anomalies and ensure timely resolution

Benefits

  • Competitive pay
  • Opportunities for professional growth within a growing team
Full Job Description
We are looking for a Systems V&V Engineer to join our growing team in Irvine, CA United States!

Essential Functions:
  • Verification activities and take ownership of deliverables, including protocols, reports, and logs.
  • 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:
  • 2+ 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:

  • A Competitive pay, the salary range for the role is $80,000 - $90,000.


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

About QualiTest Group

Size
3,500 employees
Industry
Founded
1983

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