R&D Project Manager

vor 2 Wochen


Genève, Schweiz AXEPTA SA Vollzeit

Responsibilities:

- Contribute to the design and development of new products
- Coordinate multiple projects simultaneously
- Interact with the different departments of the company, intervening in the different stages of the projects, from design to product launch
- Contribute to the maintenance of existing product lines
- Ensure compliance with applicable regulatory requirements ISO 13485, 21CFR Part 820 and MDR 2017/745 (EU)
- You will be responsible for prototyping and manufacturing test devices in collaboration with internal and external manufacturers
- Establish test plan, execute or monitor tests
- Contribute to the design transfer of new products
- Write all associated documentation, perform risk analysis and design verification/validation master plan in accordance with regulatory and quality requirements
- Manage the design history file (DHF) for the project

Your profile:

- Mechanical engineering degree or equivalent with a minimum of 5 years of experience as a project manager in R&D in the Medical Device industry
- Experience with spinal products mandatory
- Knowledge of standards and regulations associated with medical devices such as ISO 13 485, 21CFR Part 820 and MDR 2017/745 (EU)
- Knowledge/experience with SolidWorks is a plus
- Fluent in English ; French is an asset


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