Senior Manager PET V&V

Required Senior Manager PET V&V
Job Description Summary
The PET V&V Manager will lead and oversee all Verification and Validation activities for Positron Emission Tomography (PET) systems and components, ensuring product quality, regulatory compliance, and successful product launches within
Job Description
Job Responsibilities:
* Lead and manage a group of 30-40 V&V engineers and technicians, including team leads, with responsibility for 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 our 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

דרישות:

* 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