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, 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.
Requirements: * 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.
This position is open to all candidates.