Software Engineer

Software Engineer

📍 [Location | Remote]

-Contract role with 6+ months initial duration

Role Summary

We are seeking a Software Engineer with medical device design controls expertise to support design controls remediation activities for device software. This role is focused on software‑specific gap assessment and remediation across Design Inputs, Design Outputs, Verification & Validation (V&V), and Risk Management, ensuring compliance with FDA 21 CFR 820 and IEC 62304 software lifecycle requirements.

This position is ideal for engineers experienced in software documentation remediation, audit readiness, and legacy or in‑flight medical device programs.

Key Responsibilities

• Perform software design controls gap assessments for requirements, architecture, and detailed design documentation
• Remediate software Design Inputs and Design Outputs to align with IEC 62304 and FDA expectations
• Support software risk analysis (e.g., hazard analysis, SOUP assessments) and ensure alignment with the overall Risk Management File (ISO 14971)
• Develop, update, and execute unit‑level and integration verification protocols, reports, and traceability matrices
• Identify software cybersecurity and usability/human factors gaps and recommend risk‑based mitigations
• Ensure software lifecycle documentation supports Design Transfer readiness and regulatory inspection preparedness
• Partner cross‑functionally with Quality, Systems, Cybersecurity, and Human Factors teams

Required Qualifications

• Bachelor’s degree or higher in Software Engineering, Computer Science, or related field
• Medical device software development experience under IEC 62304 and 21 CFR 820
• Strong experience with software design controls, requirements management, and configuration management
• Hands‑on experience with software remediation or gap assessment projects (legacy devices, audits, acquisitions, or DHF updates)
• Familiarity with FDA cybersecurity guidance, threat modeling, and software risk mitigation
• Exposure to usability engineering / human factors as applied to software‑driven medical devices

Why Join Us

• Contribute to meaningful remediation work that directly impacts patient safety and regulatory success.
• Collaborate with experienced quality, clinical, and engineering professionals.
• Flexible work arrangements depending on location and engagement needs.