Verification & Validation (V&V) Manager

Description:

Eitan Medical is a fast-growing global medical device company that develops and manufactures innovative drug-delivery and infusion solutions across the continuum of care, from hospital to home. We are looking for an experienced V&V Manager to lead our V&V function and team within the R&D

Job Description 

• Lead the V&V function and define the verification and validation strategy for new products and design changes. 
• Manage, develop, and provide technical leadership to a multidisciplinary team of V&V engineers, including goal setting, workload allocation, mentoring, and performance development. 
• Ensure complete, risk-based test coverage and traceability from product and system requirements through test evidence and final reports. 
• Review and approve V&V plans, protocols, reports, deviations, and supporting technical documentation. 
• Oversee system-level hardware, software, mechanical, and disposable-set testing in the R&D laboratory and at external laboratories and subcontractors. 
• Lead experimental design, data analysis, structured problem-solving, and root-cause investigations. 
• Plan resources, equipment, schedules, and priorities, and monitor execution against project milestones and quality objectives. 
• Partner with Systems, R&D, Quality, Regulatory, Clinical, and Project Management teams, and provide V&V support during audits and regulatory submissions. 

Reports to: R&D Director 

• B.Sc. in Biomedical, Systems, Electrical, Mechanical, or a related engineering discipline. 
• At least 5 years of R&D experience in the medical-device industry, including at least 2 years of direct management experience leading technical or V&V staff. 
• Hands-on experience planning and leading system-level V&V for multidisciplinary medical devices combining hardware and software. 
• Strong knowledge of medical-device design controls, requirements traceability, risk-based V&V, and quality-system requirements. 
• Demonstrated experience developing, reviewing, and approving V&V strategies, plans, protocols, reports, and test deviations. 
• Strong leadership, project-management, analytical, and root-cause investigation skills. 
• Excellent cross-functional communication and stakeholder-management skills, with the ability to manage multiple priorities. 
• Fluent written and spoken English. 

Advantages 

• Experience with infusion pumps, drug-delivery systems, or other active medical devices. 
• Working knowledge of relevant standards, such as ISO 13485, ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 62304, and IEC 62366-1. 
• Experience managing external laboratories and electrical safety, EMC, reliability, usability, or environmental testing. 
• Experience with sterilization validation process using EtO or radiation.  
• Experience with test automation, statistical analysis, or V&V performance metrics. 
• M.Sc. in Engineering or a related field.