Software Design Control Engineer

• Work alongside software engineers to author, review, and maintain comprehensive design control documentation, including Software Requirements Specifications, Architecture & Design Documents, and Traceability Matrices.
• Ensure software development processes align with IEC 62304 (Medical Device Software Lifecycle), ISO 13485, and FDA 21 CFR Part 820 regulations.
• Author and maintain software risk management files, including Software FMEAs per ISO 14971.
• Produce software verification and validation (V&V) protocols and reports in coordination with the engineering and test teams to ensure full traceability.
• Compile and organize necessary software technical documentation for regulatory submissions.
• Maintain and update software documentation for post-market surveillance, CAPAs, and software updates.

• 5+ years of experience in the medical device industry, specifically working with software‑driven or connected medical devices (Class II or Class III).
• A Bachelor’s degree in Computer Science, Biomedical Engineering, Software Engineering, or a related field, or equivalent practical engineering experience.
• Demonstrated experience writing, reviewing, and managing formal medical device software documentation (Design History Files, Traceability Matrices).
• Proven track record of taking a medical device software product through a successful FDA clearance/approval process and subsequent launch.
• Deep familiarity with IEC 62304, ISO 14971, and FDA Software Validation Guidelines.
• Experience with modern software development workflows (e.g. Git, Jira) and quality system tools (e.g. Greenlight Guru, Arena, Matrix Requirements, or Jama).

Expertise in authoring and managing medical device software documentation, including compliance with IEC 62304, ISO 14971, and FDA regulations. Proven ability to navigate the FDA clearance process for software‑driven medical devices.