Job Responsibilities
* Lead and manage a team of V&V engineers and technicians, including hiring, training, performance management, and career development.
* Develop, implement, and maintain comprehensive V&V strategies, plans, and protocols for PET systems, subsystems, and software, adhering to GE Healthcare's quality systems and regulatory requirements (e.g., FDA, CE).
* Oversee the execution of V&V activities, including test case development, test execution, defect management, and results analysis, ensuring thorough coverage and traceability to requirements.
* Collaborate closely with R&D, System Engineering, Quality Assurance, Regulatory Affairs, and Project Management teams throughout the product development lifecycle to define requirements, design testability, and ensure V&V deliverables are met on time and within budget.
* Drive continuous improvement in V&V processes, tools, and methodologies, incorporating industry best practices and lessons learned.
* Review and approve V&V documentation, including test plans, reports, and traceability matrices, ensuring accuracy and completeness.
* Participate in design reviews, risk assessments, and post-market surveillance activities to identify potential V&V implications.
* Represent the V&V team in internal and external audits, providing evidence of compliance and addressing any findings.
* Stay abreast of new technologies, industry standards, and regulatory changes relevant to PET imaging and V&V.
Job Qualifications
* Bachelor's degree in Biomedical Engineering, Electrical Engineering, Physics, or a related technical field. Master's degree preferred.
* Minimum of 8 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 quality systems (e.g., ISO 13485) and regulatory requirements (e.g., FDA 21 CFR Part 820, IEC 62304).
* Proven ability to lead, mentor, and motivate technical teams.
* Excellent analytical, problem-solving, and decision-making skills.
* Strong written and verbal communication skills, with the ability to effectively communicate complex technical information to diverse audiences.
* Experience with V&V tools and methodologies (e.g., requirements management tools, test management software, statistical analysis).
* Ability to work effectively in a fast-paced, dynamic environment.
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.
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Additional InformationThe job is open to men and women equally
Relocation Assistance Provided: No