Senior Product Development Engineer

vor 1 Monat

Le Locle, Schweiz Randstad (Schweiz) AG Vollzeit

We are currently seeking a Senior Product Development Engineer for one of our clients in Canton of Neuchatel.

If you are looking to work in a dynamic and very friendly working environment in the medical devices sector, then this is for you.

This is an open-ended temporary contract.

Please note this vacancy requires fluency in French.

The Senior Product Development Engineer works as a member of the sustaining engineering team on the development of products in Integra’s drainage portfolio to the latest compliance standards.

The Senior Product Development Engineer will be responsible for design modifications of existing products, including the full product development cycle required by the latest quality system.

Your responsibilities:
  • Understanding of Medical Device-New product development and Sustaining Engineering Process.
  • Working knowledge of Technical files and Medical Device product development process.
  • Knowledge of current European Medical Device directives (MDD/MDR) and CE Mark process.
  • Experience in performing/coordinating projects involving the design process.
  • Experience in QMS, Tech File, DHF and Risk Management File.
  • Understanding of Medical regulatory standards is preferred (EU Regulations – MDD & MDR).
  • Knowledge on Part 820, Part 11, ISO 13485, MDD/IVDD, IEC 60601x, IEC 62304, ISO 14971.
  • Knowledge in DFMEA, PFMEA, GD&T and Design documentation processes.
  • Experience in the creation of Protocols, Testing and Verification including product usability is required.
  • Should be capable of owning the project from beginning to completion.
  • Hardworking and able to work individually on design with good problem-solving skills.
  • Should have good communication skills to be able to communicate with stakeholders, project managers, and outside vendors.
  • Experience with MS Project and MS Office.
Your profile:
  • Experience: minimum 5 years’ experience in mechanical design and new product development of medical devices.
  • Education: Bachelor’s degree in Mechanical Engineering or similar engineering discipline (Master’s degree in mechanical or biomedical engineering preferred).
  • Strong time/project management skills (preferably experience using Microsoft Project or another project management software).
  • Fluent in English and French.
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