Systems Design​/Product Development Engineer

Systems Design / Product Development Engineer

This role is open to remote candidates able to work Mountain Time hours, though candidates based onsite in Salt Lake City, UT are preferred.

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 ISO
  62304 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.