Senior Product Development Engineer

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p>Understanding of Medical Device-New product development and Sustaining Engineering Process,

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p>Working knowledge of Technical files and Medical Device product development process,

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p>Knowledge of current European Medical Device directives (MDD/MDR) and CE Mark process,

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p>Experience in performing/coordinating projects involving design process,

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p>Experience in QMS, Tech File, DHF and Risk Management File,

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p>Understanding of Medical regulatory standards is preferred (EU Regulations – MDD & MDR)

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p>Knowledge on Part 820, Part 11, ISO 13485, MDD/IVDD, IEC 60601x, IEC 62304, ISO 14971,

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p>Knowledge in DFMEA, PFMEA, GD&T and Design documentation processes,

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p>Experience in creation of Protocols, Testing and Verification including product usability is required,

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

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

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

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p>Experience with MS Project, MS Office 

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p>Your profile: 

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p>Experience: minimum 5 years’ experience in mechanical design and new product development of medical devices

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p>Education: Bachelor’s degree in Mechanical Engineering or similar engineering discipline (Master’s degree in mechanical or biomedical engineering preferred)

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p>Strong time/project management skills (preferably experience using Microsoft Project or another project management software)

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p>English and French fluent