Verification & Validation (V&V) Manager
Core
Lead the Verification & Validation (V&V) function and strategy for new drug-delivery and infusion medical devices, ensuring risk-based test coverage and traceability from requirements to final reports.
Role type
Senior management-level V&V Manager
Builds
Multidisciplinary medical devices combining hardware, software, and mechanical systems
Domain
Medical device industry (drug-delivery and infusion solutions)
Required skills
V&V strategy definition, team leadership and mentoring, risk-based testing, requirements traceability, system-level testing (hardware/software/mechanical), experimental design, data analysis, root-cause investigation, project management, cross-functional collaboration
Preferred skills
Experience with infusion pumps and drug-delivery systems, knowledge of ISO 13485/14971/IEC 60601 standards, managing external laboratories, sterilization validation (EtO/radiation), test automation, statistical analysis (via careerplan.io/jobs/C6-00F-35-273-verification-validation-vv-manager-at-eitan-medical)
Technologies
ISO 13485, ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366-1
Responsibilities
Define V&V strategy for new products and design changes, manage and mentor a multidisciplinary V&V team, review and approve V&V plans/protocols/reports, oversee system-level testing in R&D and external labs, lead experimental design and root-cause investigations, partner with R&D/Quality/Regulatory teams for audits and submissions
Seniority
Manager, hands-on leadership