Senior Project Manager

vor 3 Wochen


Genf, Genf, Schweiz AXEPTA SA Vollzeit

We are seeking a seasoned Senior Project Manager to spearhead medical device R&D projects, particularly in spinal arthroplasty. This role offers a unique opportunity to collaborate with an innovative team dedicated to advancing healthcare technologies and improving patient outcomes.

Key Responsibilities:

  • Lead the development of arthroplasty products from design inputs to product launch
  • Develop and implement market access strategies for U.S. (PMA) and European markets (CE marking)
  • Manage multiple projects simultaneously, ensuring compliance with regulatory requirements, including ISO 13485, 21 CFR Part 820, and MDR 2017/745 (EU)
  • Collaborate with cross-functional teams, including Marketing, Operations, and RA/QA, at every stage of projects
  • Contribute to the design, development, and maintenance of new and 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, conduct risk analysis, and develop 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, particularly in spine, orthopedics, or related industries
  • Proficiency in English and French (written and spoken, with recent professional usage)
  • Computer skills (Word, Excel, PowerPoint, Teams, etc.)


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