SW Development Engineer

Systems Design / Product Development Engineer (SaMD)

Position Summary
Seeking a Systems Design / Product Development Engineer to support the development of a Software as a Medical Device (SaMD). This role is responsible for creating and maintaining Design History File (DHF) documentation, supporting systems engineering activities, and ensuring compliance with FDA and quality standards throughout the product lifecycle.

Location: Remote (must work Mountain Time); Salt Lake City, UT candidates preferred.

Responsibilities

• Create and maintain DHF documentation, including requirements, design inputs, traceability, and risk documentation.
• Support risk management activities (FMEA) and usability engineering.
• Assist with verification & validation (V&V), including test planning, execution, and reporting.
• Collaborate with Engineering, QA, Clinical, and Regulatory teams.
• Maintain requirements traceability and support regulatory audits.

Qualifications

• 3+ years of systems engineering or product development experience in a regulated environment.
• Experience with SaMD, DHF, and FDA design controls.
• Knowledge of ISO 14971; IEC 62304 and IEC 62366 are a plus.
• Experience with QMS and requirements tools such as Codebeamer, Jira, or similar.
• Strong communication and technical documentation skills.
• Bachelor’s degree in Engineering or a related field; Biomedical Engineering preferred.