Software Systems Engineer (Medical Devices)

The Software Engineer will support design controls remediation activities with a focus on software components of medical devices. This role involves conducting gap assessments and remediation across Design Inputs, Design Outputs, Verification & Validation (V&V), and Risk Management to ensure compliance with FDA regulations and IEC 62304 standards., * Perform gap assessments and remediation of software requirements, architecture, and detailed design documentation

• Support software risk analysis and ensure alignment with the overall device risk management file
• Develop and update unit and integration verification protocols, including traceability matrices
• Identify gaps related to cybersecurity and usability in software design outputs and recommend appropriate mitigation strategies
• Ensure software lifecycle documentation meets Design Transfer readiness requirements
• Collaborate with cross-functional teams to ensure compliance with regulatory and quality standards

• Bachelor's degree in Software Engineering, Computer Science, or a related field
• Hands-on experience in medical device software development under IEC 62304 and FDA 21 CFR Part 820
• Strong knowledge of software design controls, requirements management, and risk management processes
• Experience with software gap assessments and remediation projects
• Familiarity with FDA cybersecurity guidance and usability engineering principles

Preferred Skills

• Experience working in regulated environments with design controls remediation initiatives
• Strong analytical, documentation, and problem-solving skills
• Ability to work independently in a remote, cross-functional environment