Our client, a Medical Devices/Healthcare company, is looking for a Systems Design / Product Development Engineer for their Salt Lake City, UT/Remote location. Responsibilities:

+ Draft and maintain DHF content including user needs, system/design requirements, software requirement specifications, design inputs, traceability matrices, and risk

+ documentation

+ Support risk analysis activities (e.g. FMEAs) and contribute to usability engineering activities

+ Support V&V activities including drafting, execution and creation of test cases, reports and other testing artifacts

+ Collaborate cross-functionally with R&D, QA, Clinical, and Regulatory to translate technical information across stakeholder groups

Requirements:

+ 5+ years of experience in systems design/product development within a multi-disciplinary organization

+ Demonstrated experience with SaMD development and regulatory documentation
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