Innovative R&D Project Manager for Medical Devices
vor 14 Stunden
Axepta SA is a fast-growing company specialized in Medical Devices, with a strong presence in the global market.
Job SummaryWe are seeking an experienced R&D Project Manager to join our team. The ideal candidate will have a mechanical engineering background and a minimum of 5 years of experience in project management within the Medical Device industry.
Responsibilities:- Contribute to the design and development of new products, ensuring compliance with regulatory requirements such as ISO 13485, 21CFR Part 820 and MDR 2017/745 (EU).
- Collaborate with internal and external manufacturers to prototype and manufacture test devices.
- Establish test plans, execute or monitor tests, and contribute to the maintenance of existing product lines.
- Manage the design history file (DHF) for the project and ensure all associated documentation is written, including risk analysis and design verification/validation master plan.
- Mechanical engineering degree or equivalent.
- Minimum of 5 years of experience as a project manager in R&D in the Medical Device industry.
- Experience in spinal products mandatory.
- Knowledge of standards and regulations associated with medical devices.
- Fluent in English; French is an asset.
We offer a competitive salary, estimated at around $120,000 per year, depending on experience, plus a comprehensive benefits package, including health insurance and retirement savings.
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