Medical Device R&D Project Manager Opportunity

vor 1 Tag


Genf, Genf, Schweiz Axepta SA Vollzeit
About Axepta SA
As a renowned innovator in the field of surgery, we specialize in Medical Devices. Our company is based in Geneva and prides itself on being a fast-growing industry leader.

Job Description:
We are seeking an experienced R&D Project Manager to contribute to the design and development of new products. This role will involve coordinating multiple projects simultaneously, interacting with various departments, and ensuring compliance with regulatory requirements such as ISO 13485, 21CFR Part 820, and MDR 2017/745 (EU).

Responsibilities:
- Design and develop new products for our medical device portfolio
- Coordinate multiple projects simultaneously to ensure timely delivery
- Collaborate with internal and external manufacturers to prototype and manufacture test devices
- Establish test plans and execute or monitor tests to ensure product quality
- Contribute to the design transfer of new products and maintain existing product lines
- Develop and maintain documentation, perform risk analysis, and design verification/validation master plans according to regulatory and quality requirements
- Manage the design history file (DHF) for each project

Your Profile:
- Mechanical engineering degree or equivalent with a minimum of 5 years of experience as a project manager in R&D for Medical Devices
- Experience in spinal products is mandatory
- Knowledge of standards and regulations associated with medical devices is essential
- Knowledge/experience with SolidWorks is a plus
- Fluency in English is required; French is an asset

Why Join Us?
Axepta SA offers a dynamic work environment and opportunities for professional growth. We strive to be at the forefront of innovation in the medical device industry.

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