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Product Engineering Manager

vor 1 Woche

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 Role

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

Key Responsibilities:

  • Understand and implement Medical Device-New product development and Sustaining Engineering Process;
  • Develop and maintain technical files and Medical Device product development process;
  • Stay up-to-date on current European Medical Device directives (MDD/MDR) and CE Mark process;
  • Lead and coordinate projects involving design process;
  • Maintain and improve QMS, Tech File, DHF and Risk Management File;
  • Familiarity with 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;
  • Expertise in DFMEA, PFMEA, GD&T and Design documentation processes;
  • Develop and execute Protocols, Testing and Verification including product usability;
  • Owning the project ownership from beginning to project completion;
  • Good problem-solving skills and ability to work independently;
  • Effective communication skills to interact with stakeholders, project managers, outside vendors;
  • Proficiency in MS Project, MS Office;
About You

To succeed in this role, you will need:

  • Minimum 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.