Senior Medical Device Development Manager

vor 10 Stunden


Genf, Genf, Schweiz Axepta SA Vollzeit

We are seeking a highly skilled Senior Medical Device Development Manager to join our team at Axepta SA, a renowned innovator in the field of surgery based in Geneva. This is an excellent opportunity for an experienced professional to contribute to the design and development of new medical products.

Job Summary

The Senior Medical Device Development Manager will be responsible for leading multiple projects simultaneously, ensuring compliance with regulatory requirements, and collaborating with internal and external manufacturers to deliver high-quality products.

Responsibilities:
  • Contribute to the design and development of new medical products, taking into account safety, efficacy, and user experience.
  • Coordinate multiple projects simultaneously, prioritizing tasks and managing timelines to ensure successful project delivery.
  • Collaborate with cross-functional teams, including engineering, quality, and regulatory affairs, to ensure compliance with applicable regulations, such as ISO 13485, 21CFR Part 820, and MDR 2017/745 (EU).
  • Develop and implement test plans, execute or monitor tests, and ensure that all associated documentation is accurate and compliant.
  • Manage the design history file (DHF) for each project, ensuring that all relevant documentation is up-to-date and compliant with regulatory requirements.
  • Work closely with manufacturing partners to develop and implement manufacturing processes that meet regulatory requirements.
Requirements:
  • Master's degree in Mechanical Engineering or a related field, or equivalent experience.
  • Minimum 5 years of experience as a project manager in R&D in the Medical Device industry.
  • Proven track record of delivering successful projects on time and within budget.
  • Experience in spinal products and knowledge of regulatory requirements, including ISO 13485, 21CFR Part 820, and MDR 2017/745 (EU).
  • Fluent in English; French is an asset.
Estimated Salary: €80,000 - €120,000 per year

Our ideal candidate is a strategic thinker with excellent communication and project management skills. If you are passionate about developing innovative medical products and have a strong background in project management, we encourage you to apply for this exciting opportunity.



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