Senior Project Manager

Vor 3 Tagen


Geneva, Schweiz AXEPTA SA Vollzeit

We are recruiting on behalf of one of our prestigious clients for a Senior Project Manager specializing in medical devices. This role is a unique opportunity to join an innovative R&D team dedicated to advancing healthcare technologies, improving patient outcomes, and shaping the future of spinal arthroplasty.

Senior Project Manager – Medical Device R&D

 

Your main responsibilities will include:

 

  • Leading arthroplasty product development activities

  • Developing, in collaboration with the regulatory department, a strategy to access U.S. (PMA) and European markets (CE marking)

  • Managing multiple projects simultaneously

  • Complying with applicable regulatory requirements, including ISO 13485, 21 CFR Part 820, and MDR 2017/745 (EU)

  • Collaborating with various teams within the organization (Marketing, Operations, RA/QA) at each stage of projects, from design inputs to product launch

  • Participating in the design and development of new products as well as in the maintenance of existing product lines

  • Defining and validating design requirements

  • Ensuring prototyping and manufacturing of test devices in coordination with internal and external manufacturers

  • Contributing to the design transfer of new products

  • Preparing documentation, conducting risk analysis, and developing the Design Verification/Validation Master Plan, in compliance with regulatory and quality requirements

  • Creating and maintaining the Design History File (DHF) related to the project

 

Who you are:

 

  • 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.)

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