Technical Leader Verification & Validation (M/F)
Reporting to the Head of the Electro-Medical Devices Department within the R&D Division, you will be the technical referent for Hardware Verification & Validation activities.
Your mission consists of defining and driving the V&V strategy for products in order to demonstrate their compliance with functional, performance, safety, and regulatory requirements throughout their entire life cycle.
WHAT WILL BE YOUR MAIN ACTIVITIES?
- define, justify, and drive the Verification & Validation strategy for devices developed by Hardware R&D.
- Develop test plans and ensure product requirement coverage.
- Organize and prioritize internal and external testing campaigns.
- Perform or coordinate the execution of verification and validation tests.
- Analyze results, conduct investigations, and manage the handling of deviations.
- Ensure requirement traceability and demonstration of compliance.
- Produce and approve V&V deliverables: protocols, test reports, validation summaries, and coverage indicators.
- Support certification projects and international regulatory registration.
- Standardize and improve V&V methods, processes, and tools.
- Provide technical leadership to multidisciplinary teams involved in testing activities.
A graduate of an engineering school or holder of a Master's degree (Bac+5) in biomedical, mechatronics, electronics, quality, or an equivalent field, you have at least 5 years of experience in Verification & Validation within the medical device and/or electro-medical industry in ISO 13485 and FDA certified companies.
You have already managed complex V&V activities and coordinated technical teams in a regulated environment. Professional English is required.
You possess solid knowledge in: Verification & Validation methodologies. Requirements management and traceability. Development of V&V strategies and plans. Writing of protocols and test reports. Analysis of results and investigation management. Validation of complex systems integrating hardware, software, and user interfaces. Human factors and usability engineering (IEC 62366). Risk management applied to medical devices (ISO 14971). Knowledge of the following areas would be appreciated:
- Biocompatibility (ISO 10993)
- Electrical safety and electromagnetic compatibility (IEC 60601)
- Reprocessing (ISO 17664)
- Transport and packaging (ASTM D4169, ISTA 3A)
Start date: as soon as possible