Systems Design Product Development Engineer

W2 only, no C2C please!
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.ResponsibilitiesDraft and maintain DHF content including user needs, system/design requirements, design inputs, traceability matrices, and risk documentationDefine clear, testable requirements and support traceability across the design history fileSupport risk analysis activities (e.g. FMEAs) and contribute to usability engineering activitiesSupport V&V activities including drafting, execution and creation of test cases, reports and other testing artifactsCollaborate cross-functionally with R&D, QA, Clinical, and Regulatory to translate technical information across stakeholder groupsRequirements5+ years of experience in systems design/product development within a multi-disciplinary organizationDemonstrated experience with SaMD development and regulatory documentationWorking knowledge of ISO 14971; familiarity with ISO62304 and IEC 62366 preferredExperience 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 judgmentExcellent written and verbal communication skills, with ability to work effectively with internal and external collaboratorsExperience with Codebeamer, JIRA, or similar requirements/traceability toolingEducationBachelor's degree in Engineering or a related science field; Biomedical Engineering preferred.