R&d Project Manager

vor 2 Wochen


Geneva, 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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