Senior Spine Project Development Lead
vor 2 Monaten
We are seeking an experienced R&D Project Manager to join our team at AXEPTA SA in Geneva, specializing in Medical Devices. As a key member of our innovative spine products development team, you will play a crucial role in driving project success and ensuring compliance with regulatory requirements.
The ideal candidate will have a strong background in mechanical engineering or a related field, with a minimum of 5 years of experience as a project manager in the Medical Device industry. Experience with spinal products is mandatory, and knowledge of standards and regulations such as ISO 13485, 21CFR Part 820, and MDR 2017/745 (EU) is essential.
About the RoleThis is a challenging opportunity for a motivated professional to lead projects from design to product launch, while maintaining existing product lines and ensuring adherence to quality and regulatory requirements. Key responsibilities include:
- Designing and developing new products in collaboration with internal and external manufacturers;
- Establishing test plans, executing tests, and monitoring test results;
- Contributing to design transfers of new products and writing associated documentation;
- Managing the design history file (DHF) for the project;
- Ensuring compliance with applicable regulatory requirements;
To be successful in this role, you will need:
- A degree in Mechanical Engineering or equivalent;
- A minimum of 5 years of experience as a project manager in the Medical Device industry;
- Experience with spinal products;
- Knowledge of relevant industry standards and regulations;
- Familiarity with SolidWorks is a plus;
- Fluency in English; French is an asset;
AXEPTA SA offers a competitive salary range of approximately CHF 90,000 - 110,000 per annum, depending on experience. Additionally, we provide a comprehensive benefits package, including health insurance, retirement plan, and opportunities for professional growth and development.
Please note that the estimated salary range is based on industry standards and location factors, and may vary depending on individual circumstances.
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