R&D Project Manager

vor 1 Monat


Genf, Schweiz AXEPTA SA Vollzeit

Responsibilities:

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

Your profile:

  1. 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
  2. Experience with spinal products mandatory
  3. Knowledge of standards and regulations associated with medical devices such as ISO 13485, 21CFR Part 820 and MDR 2017/745 (EU)
  4. Knowledge/experience with SolidWorks is a plus
  5. Fluent in English; French is an asset
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