Systems Design Engineer
LancesoftSalt Lake City, UT
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Overview
Remote
On-site
Job Description
Job Title: Systems Design / Product Development EngineerLocation: Salt Lake City, UTDuration: 5 Months till year end 12/31/2026Job 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. 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
- 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
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FAQs About Systems Design Engineer Jobs at Lancesoft
What is the work location for this position at Lancesoft?
This job at Lancesoft is located in Salt Lake City, UT, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Lancesoft?
Candidates can expect a pay range of $55.
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