5plus 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
Job Title: Systems Design / Product Development Engineer
Duration - 6 Months
Location - Remote in MST
Note - This role is open to remote candidates able to work Mountain Time hours, though candidates based onsite in Salt Lake City, UT are preferred.
Job Description
We're looking for a Systems Design / Product Development Engineer to support development of a software-based medical device (SaMD). The ideal candidate has a solid foundation in systems engineering and product development within a regulated environment, with hands-on experience drafting and maintaining design history file (DHF) content. This role plays a key part in refining and updating existing product documentation and ensuring continued regulatory alignment as the product moves through its lifecycle.
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
• Experience drafting DHF artifacts (user needs, requirements, traceability matrices, risk files)
• Experience in a regulated, compliance-driven environment (FDA/QMS)\
• Strong analytical skills and sound technical judgment
• Excellent written and verbal communication skills, with ability to work effectively with
internal and external collaborators
• Experience with Codebeamer, JIRA, or similar requirements/traceability tooling
Education
Bachelor's degree in Engineering or a related science field; Biomedical Engineering preferred.
