senior product development engineer.

• 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,

• Should be capable of owning the project ownership from beginning to project completion,

• Hardworking and should be individual working for design and good Problem-solving skills,

• Should have good communication skills to be able to communicate with steak holders, project managers, outside vendors,

• Experience with MS Project, 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)

• English and French fluent