V&V Manager, PET IB

Job Description Summary

The V&V Manager, PET IB will lead and manage the verification and validation activities for PET (Positron Emission Tomography) Integrated Systems and components. This role is critical in ensuring the safety, effectiveness, and regulatory compliance of GE HealthCare innovative PET imaging solutions.

Job Description

• Lead and manage a team of V&V engineers, including resource allocation, performance management, and professional development.
• Develop, implement, and maintain comprehensive V&V strategies, plans, protocols, and reports in accordance with internal procedures and relevant regulatory standards (e.g., FDA, ISO 13485, IEC 60601).
• Oversee the execution of all V&V activities for PET IB (Integrated Systems/Solutions), including system-level testing, integration testing, and performance verification.
• Collaborate closely with R&D, System Engineering, Clinical, Regulatory Affairs, and Quality Assurance teams throughout the product development lifecycle to ensure V&V requirements are clearly defined and met.
• Define and review test cases, test procedures, and test environments to ensure thorough and effective validation of product requirements and design specifications.
• Manage and track defects, ensuring timely resolution and re-verification.
• Participate in design reviews, risk assessments, and FMEAs (Failure Mode and Effects Analysis) to identify potential issues and ensure V&V coverage.
• Prepare and present V&V status, progress, and results to stakeholders and management.
• Drive continuous improvement initiatives within the V&V process and methodologies.
• Ensure all V&V documentation is complete, accurate, and audit-ready.
  
  

Job Qualifications

• Bachelor's or Master's degree in Biomedical Engineering, Electrical Engineering, Software Engineering, or a related technical field.
• Minimum of 7 years of experience in Verification and Validation within the medical device industry, with at least 3 years in a leadership or management role.
• Demonstrated experience with PET or other medical imaging modalities is highly preferred.
• Strong understanding of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304, IEC 60601).
• Proven ability to lead, mentor, and motivate a technical team.
• Experience with various testing methodologies, tools, and automation frameworks.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong written and verbal communication skills in English, with the ability to effectively communicate complex technical information to diverse audiences.
• Experience working in an Agile development environment is a plus.
  
  

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information

The job is open to men and women equally

Relocation Assistance Provided: No