VERIFICATION & VALIDATION TECHNICAL LEADER

Koelis is a Grenoble-based MedTech company with about a hundred employees, specializing in imaging and guidance medical devices for urological surgery, particularly in the management of prostate cancer. The company is growing, with a strong international dimension and products present in more than 50 countries. It maintains an agile, human-sized operation with a strong culture of innovation.

YOUR MISSION

Reporting to the Head of the Electro-Medical Devices Division within the R&D Department, you are the technical referent for the Verification & Validation activities of the Electro-Medical Devices division. Your mission consists of contributing to defining, structuring, and driving the V&V strategy for KOELIS products, with a global vision of the V-model, while remaining very operational: writing protocols, managing tests, analyzing results, and monitoring external partners. You intervene from the design stage in order to integrate testing constraints and contribute to validation decisions.

YOUR MAIN ACTIVITIES

• Contribute to defining, formalizing, and evolving the Verification & Validation strategy for products and evolutions developed by the Electro-Medical Devices division.
• Develop verification and validation plans, test plans, and associated summary documents, ensuring requirement coverage and traceability.
• Intervene upstream of developments to identify functions to be tested, integrate testing constraints, and contribute to "design for testing."
• Write protocols, organize and prioritize test campaigns, then analyze results, conduct investigations, and manage the handling of deviations.
• Coordinate tests carried out mostly with external laboratories and partners, and occasionally participate in internal tests.
• Contribute to validation decisions and challenge technical design choices when necessary.
• Standardize and improve V&V methods, processes, and tools, and disseminate best practices to the teams.
• Functionally lead the multidisciplinary teams involved: R&D Hardware and Software, Quality, Regulatory Affairs, Clinical, Industrialization/Production, and Marketing.

YOUR PROFILE

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 ideally have at least 5 years of experience in Verification & Validation, primarily in the medical device industry. Less experienced profiles may be considered depending on their level of autonomy and mastery of the profession:

• You know how to contribute to defining a V&V strategy and maintain a general vision while remaining close to the field and testing activities.
• You master requirements management and traceability, protocol and report writing, results analysis, and deviation handling.
• You are aware of risk management applied to medical devices. Experience or awareness of human factors and usability is a real asset.
• Knowledge of biocompatibility (ISO 10993) and/or IEC 60601 / EMC is a plus, but not indispensable for taking the position.
• Experience in medical devices, particularly in electromechanics, medical imaging, diagnostics, surgical robotics, or instrumentation, will be particularly appreciated. Backgrounds from other highly regulated environments, such as automotive or aeronautics, may also be considered.
• Autonomous and versatile, you demonstrate an open mind, pedagogical skills, rigor, and good interpersonal skills. You are comfortable in a functional leadership role, without direct hierarchical management.
• Professional English is required.

JOB DETAILS

• Remuneration and benefits: From €45,000 gross annual + variable based on objectives + Day rate package (214 days) + meal vouchers (€10.00 per day, 60% covered by the company) + Teleworking charter: 2 days per week
• Position based in Meylan: Near Grenoble
• Start date: As soon as possible
• Contract type: CDI (Permanent contract)

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