5+ years of experience in systems design/product development within a multi-disciplinary organization
Demonstrated experience with SaMD development and regulatory documentation
Working knowledge of ISO 14971; familiarity with ISO62304 and IEC 62366 preferred
Bachelor's degree in Engineering or a related science field; Biomedical Engineering preferred
Requirements:
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 VV activities including drafting, execution and creation of test cases, reports and other testing artifacts
Collaborate cross-functionally with RD, QA, Clinical, and Regulatory to translate technical information across stakeholder groups
Job description
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
Working knowledge of ISO 14971; familiarity with ISO62304 and IEC 62366 preferred
