Systems Design/Product Development Engineer
Job in
Warsaw, Kosciusko County, Indiana, 46580, USA
Listed on 2026-07-01
Listing for:
Accede Solutions Inc
Full Time
position Listed on 2026-07-01
Job specializations:
-
Engineering
Product Engineer, Regulatory Compliance Specialist, Biomedical Engineer
Job Description & How to Apply Below
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 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.
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