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
System-level hardware, software, mechanical, and disposable-set testing for medical devices
Domain
Medical device industry (drug-delivery and infusion solutions)
Required skills
V&V strategy definition, multidisciplinary team leadership, risk-based testing, requirements traceability, experimental design, data analysis, root-cause investigation, project management, cross-functional collaboration
Preferred skills
Infusion pump/drug-delivery system experience, ISO 13485/14971/IEC 60601 knowledge, external lab management, sterilization validation (EtO/radiation), test automation, statistical analysis (via careerplan.io/jobs/C6-00F-35-273-verification-validation-vv-manager)
Technologies
V&V planning tools, statistical analysis software, test automation frameworks
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, and reports; oversee system-level testing in R&D and external labs; lead experimental design and root-cause investigations; partner with R&D, Quality, Regulatory, and Clinical teams for audits and submissions
Seniority
Senior, hands-on management