We are looking for an R&D Project Manager for one of our prestigious, world-renowned, and fast-growing clients specialized in Medical Devices.
Join an innovator in the field of surgery, located in Geneva.
Responsibilities:
* Contribute to the design and development of new products
* Coordinate multiple projects simultaneously
* Interact with different departments, intervening in various stages of projects, from design to product launch
* Maintain existing product lines
* Ensure compliance with regulatory requirements: ISO 13485, 21CFR Part 820, and MDR 2017/745 (EU)
* Prototype and manufacture test devices in collaboration with internal and external manufacturers
* Establish test plans, execute or monitor tests
* Assist in the design transfer of new products
* Document all processes, perform risk analysis, and develop design verification/validation plans according to regulatory standards
* Manage the design history file (DHF) for projects
Your profile:
* Mechanical engineering degree or equivalent with at least 5 years of R&D project management experience in the Medical Device industry
* Experience with implantable Class III Medical Devices is mandatory
* Knowledge of standards and regulations such as ISO 13485, 21CFR Part 820, and MDR 2017/745 (EU)
* SolidWorks experience is a plus
* Fluent in English; French is an asset
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