Systems Design Engineer
LanceSoft Inc
Systems Design / Product Development Engineer
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. This role is open to remote candidates able to work Mountain Time hours, though candidates based onsite in Salt Lake City, UT are preferred.
Responsibilities
- Draft and maintain DHF content including user needs, system/design requirements, design inputs, traceability matrices, and risk documentation
- Define clear, testable requirements and support traceability across the design history file
- 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.
Vacancy posted 1 day ago
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