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V&V Manager
PresencialTiempo completoSystem AssuranceMedical Devices
Lead the verification and validation function within an R&D organization developing and manufacturing medical devices. Own V&V strategy, risk-based test coverage, traceability, technical documentation, and team development.
Responsabilidades
- Define verification and validation strategies for new products and design changes.
- Lead, develop, mentor, and allocate work across a multidisciplinary V&V engineering team.
- Ensure risk-based test coverage and traceability from requirements through test evidence and final reports.
- Review and approve V&V plans, protocols, reports, deviations, and technical documentation.
- Oversee system-level hardware, software, mechanical, and disposable-set testing in internal and external laboratories.
- Lead experimental design, data analysis, structured problem-solving, and root-cause investigations.
- Plan resources, equipment, schedules, and priorities while monitoring project milestones and quality objectives.
- Collaborate with Systems, R&D, Quality, Regulatory, Clinical, and Project Management teams.
- Provide V&V support for audits and regulatory submissions.
Requisitos
- Bachelor’s degree in biomedical, systems, electrical, mechanical, or related engineering.
- At least 5 years of R&D experience in the medical-device industry, including at least 2 years managing 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.
- 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 abilities.
- Fluent written and spoken English.
Se valora
- Experience with infusion pumps, drug-delivery systems, or other active medical devices.
- Working knowledge of ISO 13485, ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 62304, or IEC 62366-1.
- Experience managing external laboratories and electrical safety, EMC, reliability, usability, or environmental testing.
- Experience with sterilization validation using EtO or radiation.
- Experience with test automation, statistical analysis, or V&V performance metrics.
- Master’s degree in engineering or a related field.