IEC 62304 Software Engineer Job Description Template

The IEC 62304 software engineer develops medical device software specifically within the lifecycle that standard defines, from planning and requirements through architecture, implementation, integration and maintenance. The role requires fluency in both the engineering and the standard, since the safety classification of the software determines how much process is required and getting that judgment wrong is expensive in either direction.

Typical Duties and Responsibilities

• Develop software following the IEC 62304 lifecycle processes
• Determine and justify software safety classification
• Produce software development plans, requirements and architecture documents
• Implement software units with documented detailed design where required
• Plan and execute integration and system testing with recorded evidence
• Maintain the software configuration management and change process
• Evaluate software of unknown provenance and document the assessment
• Support software risk analysis and traceability to mitigations
• Maintain the software maintenance and problem resolution process
• Prepare software documentation for submission and audit

Education

• Bachelor’s degree in software engineering, computer science or a related field

Required Skills and Experience

• 4+ years of medical device software development
• Detailed working knowledge of IEC 62304 and its lifecycle processes
• Experience determining software safety classification
• Understanding of the interaction between IEC 62304 and ISO 14971
• Strong programming skills in the relevant device language
• Experience producing documentation that has passed audit
• Familiarity with configuration management and change control
• Ability to advise teams on proportionate process

Preferred Qualifications

• Experience with IEC 82304 or software as a medical device guidance
• Cybersecurity documentation experience under FDA premarket guidance