Our client is a fast-growing MedTech 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.
Responsabilities
As Product Development Manager, you are responsible for the development, validation, industrialization and lifecycle management of accessory products (kits) used with the company’s medical imaging system.
You operate across the full product lifecycle in a regulated environment (ISO 13485, GMP, MDR/IVDR), working closely with internal teams, suppliers and contract manufacturing partners.
Your main responsibilities are:
- 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.
Profile
- 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.
Offer
- 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.
Your application will be treated with the utmost confidentiality, in accordance with the GDPR. PaHRtners promotes diversity, equity, and inclusion.