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Senior R&D Project Manager for Medical Device Innovation
vor 1 Woche
Company Overview
Axepta SA is a pioneering organization in the Medical Devices industry, renowned for its innovative approach to surgery.
We are seeking an experienced R&D Project Manager to join our team and contribute to the design and development of new products.
Job Description
- 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).
- Coordinate multiple projects simultaneously, interacting with different departments and intervening in various stages of the projects, from design to product launch.
- Manage the design history file (DHF) for the project and ensure compliance with applicable regulatory requirements.
- Collaborate with internal and external manufacturers to prototype and manufacture test devices, establishing test plans and executing or monitoring tests.
- Contribute to the design transfer of new products and write associated documentation, perform risk analysis, and design verification/validation master plan in accordance with regulatory and quality requirements.
Required Skills and Qualifications
- 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 in spinal products mandatory.
- Knowledge of standards and regulations associated with medical devices such as ISO 13485, 21CFR Part 820, and MDR 2017/745 (EU).
- Fluent in English; French is an asset.
Benefits
Join Axepta SA's dynamic team and take advantage of our comprehensive benefits package.
