Product Development Engineer

Overview Product Development Engineer to support the development of a Software as a Medical Device (SaMD) within a regulated medical device environment. Responsible for developing and maintaining Design History File (DHF) documentation, defining system and product requirements, supporting risk management and verification activities, and ensuring compliance with FDA Quality Management System (QMS) requirements and applicable medical device standards throughout the product development lifecycle. Location Salt Lake City, UT Duration Long Term Key Responsibilities Develop and maintain Design History File (DHF) documentation, including user needs, design inputs, system requirements, traceability matrices, and risk management files. Define clear, complete, and testable system requirements while maintaining end-to-end traceability. Support risk management activities, including FMEA and risk documentation in accordance with ISO 14971. Participate in Verification & Validation (V&V) activities by developing test protocols, executing test cases, and documenting results. Collaborate with Engineering, Quality Assurance, Clinical, and Regulatory teams to support product development activities. Ensure compliance with FDA Quality Management System (QMS) requirements and applicable regulatory standards. Support usability engineering activities following IEC 62366 guidelines. Utilize Codebeamer, JIRA, or similar requirements management and traceability tools. Contribute to continuous improvement initiatives throughout the product development lifecycle. Required Qualifications Bachelor's degree in Engineering or a related scientific discipline (Biomedical Engineering preferred). 5+ years of experience in Product Development, Systems Design, or related engineering roles within a regulated environment. Hands-on experience supporting Software as a Medical Device (SaMD) development. Strong experience creating and maintaining Design History File (DHF) documentation, including user needs, requirements, traceability matrices, and risk files. Working knowledge of ISO 14971; familiarity with ISO 62304 and IEC 62366. Experience working within FDA Quality Management System (QMS) requirements. Experience using Codebeamer, JIRA, or similar requirements management and traceability tools. Experience supporting Verification & Validation (V&V) activities. Strong analytical, technical, documentation, written, and verbal communication skills. Ability to collaborate effectively with multidisciplinary and cross-functional teams. #J-18808-Ljbffr