Senior Product Development Engineer Lead

Vor 3 Tagen


Le Locle, Neuenburg, Schweiz Randstad Professionals Vollzeit

We are currently seeking a skilled Senior Product Development Engineer to join our team in Neuchatel. This is an open-ended temporary contract that requires fluency in French.

About the Job

This role is part of sustaining engineering team on development of products in Integra's drainage portfolio to the latest compliance standards.

Key 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 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 creation of Protocols, Testing and Verification including product usability is required;
  • Candidate should be capable of owning the project ownership from beginning to project completion;
  • Hardworking and individual working for design and good Problem-solving skills;
  • Candidate should have good communication skills to be able to communicate with stakeholders, project managers, outside vendors;
  • Experience with MS Project, MS Office;
About You

To succeed in this role, you will need:

  • At least 5 years' experience in mechanical design and new product development of medical devices;
  • 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);
  • English and French fluent;

In return, we offer a competitive compensation package and opportunities for career growth and professional development.



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