we are 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
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
Requirements:
* 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.
* 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.
This position is open to all candidates.
