Our Client, a Medical Devices / Healthcare company, is looking for a System Designer for their Montreal, QC location. Responsibilities:

+ The ideal candidate will have a solid background in system design and product development, with direct experience in regulatory compliance and documentation. You’ll play a key role in refining existing product documentation and ensuring continued regulatory alignment as part of an accelerated product remediation initiative.

Requirements:

+ Candidates must have experience with software as a medical device (SaMD) concepts.

+ 5+ years of experience

+ Strong experience in system design in a multi-disciplinary organization.

+ Experience drafting and maintaining DHF (design history file) content, including user needs, system requirements, design inputs, traceability matrices, and risk documentation.

+ Able to support risk analysis (e.g uFMEA etc) and contribute to usability plan...