Senior Product Development Manager

Our client is a fast-growing Med Tech company specialized in innovative imaging solutions designed to improve precision in oncologic surgery
. With activities in Europe and the United States, the company develops breakthrough technologies enabling rapid,
high-resolution visualization of excised tissue directly in the operating room
.

Driven by a strong mission to support surgeons in making immediate and confident decisions, the company combines scientific excellence, cutting-edge technology and a tangible impact on patient outcomes.

To support its continued growth, our client is strengthening its R&D team and is looking for a Product Development Manager to take ownership of its IVD/MD accessory and consumable kits
.

• Lead and participate in development of IVD/MD accessory products under design control, in accordance with ISO 13485 from user needs definition to production transfer.
• Produce and maintain technical file documentation demonstrating regulatory compliance with EC IVD Regulations 2017/745 (MDR) and 2017/746 (IVDR) and FDA
  regulations
  .
• Establish and manage contract manufacturing organization relationships
• Establish and maintain
  quality procedures
• Discuss and solve complex problems with colleagues, sub-contractors, suppliers and customers
• Conduct training of other employees or third parties
• Conduct internal and supplier audits
• Lead and/or participate in investigations related the Company products or processes
• Participate in the management of controlled equipment (such as calibration activities, etc.)
• Manage the supply chain for the accessories in scope.
• Supports the commercial launch of the accessories in scope.
• This is a position based on full responsibility for accessory products:
• Handle detailed, complex concepts and problems, balances multiple tasks simultaneously.
• Plan and implements programs.
• Establishes strong and appropriate relationships with Head of Hardware Engineering, R&D personnel and suppliers.
• Develops smooth and constructive relationships with colleagues, outside agencies, organizations and individuals.
• Plan and meets deadlines.
• Represent adequately the company and the not-for-profit and for-profit sectors.

• At least a bachelor’s degree in a technical discipline (
  Life Sciences, Physical Sciences or Engineering
  );
  master's degree preferred
  .
• At least 5 years of experience in a relevant industry.
• Strong background with ISO 13485 and/or GMP
  , ideally involving kits or procedure packs.
• Experience in writing technical file documentation of IVD/MD medical devices.
• Concrete experience with logistics constraints and packaging design and testing (including blister packaging).
• Knowledge of plastic injection molding and/or manufacturing process of medical laboratory solutions
• Ability to plan and manage at operational levels.
• Ability to maintain open, constructive communication and collaboration with colleagues, management, and suppliers.
• Ability to prioritize and adapt to changing priorities while maintaining a high standard on quality.
• Work experience in a startup environment is desired.
• Fluent in French and English (at least Level B2
  ), both oral and written.

• A full-time position with significant responsibility and impact.
• An attractive and competitive salary package
  , aligned with your experience.
• A human-sized
  , dynamic and collaborative work environment.
• International exposure with learning and development opportunities.
• A role directly contributing to the improvement of global healthcare
  outcomes
  .