Senior Manager Pet V&v

GE HealthCare UK

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Verification and validation leadership
Pet system testing experience
Iso 13485 and fda 21 cfr part 820 knowledge
** GE HealthCare is seeking a Senior Manager for Verification and Validation (V&V) of Positron Emission Tomography (PET) systems. The candidate will lead a team of V&V engineers, ensuring product quality and regulatory compliance while driving continuous improvements in V&V processes. **

Job Summary

  • The role involves leading a large team of 30 to 40 V&V engineers to ensure product quality and regulatory compliance for PET systems.
  • Candidates must have a deep understanding of medical device quality systems including ISO 13485 and FDA regulations.
  • The position requires collaborating with R&D and Quality Assurance teams to define requirements and deliver V&V outcomes on time.

Matching Summary

Match Score: 75

** GE HealthCare is seeking a Senior Manager for Verification and Validation (V&V) of Positron Emission Tomography (PET) systems. The candidate will lead a team of V&V engineers, ensuring product quality and regulatory compliance while driving continuous improvements in V&V processes. **

Skills & Requirements

Must-have

  • Verification and Validation leadership
  • PET system testing experience
  • ISO 13485 and FDA 21 CFR Part 820 knowledge
  • IEC 62304 software validation expertise
  • Team management of 30-40 engineers

Nice-to-have

  • Continuous improvement in V&V processes
  • Experience with statistical analysis tools
  • Post-market surveillance participation
  • Strong communication with diverse audiences

Key Requirements

  • Bachelor's degree in Biomedical or Electrical Engineering
  • Minimum 8 years in medical device V&V
  • At least 3 years in a leadership role
  • Master's degree preferred
  • Experience with PET or medical imaging modalities

Work Rights

Not specified

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