Medical Device R&D Leadership Position

Vor 4 Tagen


Genf, Genf, Schweiz AXEPTA SA Vollzeit
Senior Project Manager – Medical Device R&D

We are seeking an experienced Senior Project Manager to join our innovative R&D team dedicated to advancing healthcare technologies and improving patient outcomes in the medical devices sector.

This role offers a unique opportunity to lead arthroplasty product development activities, develop market access strategies, manage multiple projects simultaneously, and collaborate with various teams within the organization.

Main Responsibilities:

  • Lead arthroplasty product development activities, ensuring compliance with regulatory requirements, including ISO 13485, 21 CFR Part 820, and MDR 2017/745 (EU)
  • Develop a strategy to access U.S. (PMA) and European markets (CE marking), in collaboration with the regulatory department
  • Manage multiple projects simultaneously, prioritizing tasks and resources effectively
  • Collaborate with Marketing, Operations, RA/QA teams at each stage of projects, from design inputs to product launch
  • Participate in the design and development of new products, as well as the maintenance of existing product lines
  • Define and validate design requirements, ensuring prototyping and manufacturing of test devices in coordination with internal and external manufacturers
  • Contribute to the design transfer of new products and prepare documentation, conducting risk analysis, and developing the Design Verification/Validation Master Plan, in compliance with regulatory and quality requirements
  • Maintain the Design History File (DHF) related to the project

Requirements:

  • Degree in mechanical engineering or equivalent, with 8 to 10 years of experience in R&D within the medical device sector
  • Proven experience as an R&D Project Manager
  • Experience in the medical device field for spine, orthopedics, or any related medical device industries
  • Proficiency in English & French (written and spoken, with recent professional usage)
  • Computer skills (Word, Excel, PowerPoint, Teams, etc.)

The estimated annual salary for this position is around $120,000 - $150,000, depending on qualifications and location.



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