Software Engineer (Medical Devices) Job Description Template

The software engineer working on medical devices develops and tests code within a quality management system, where every change is documented and traceable. The role suits engineers who are comfortable with rigour and who understand that in this field a defect can reach a patient. The technical work varies from embedded firmware to device facing applications depending on the product.

Typical Duties and Responsibilities

• Implement software features against controlled requirements
• Write unit and integration tests with documented results
• Participate in design reviews and code reviews
• Support risk analysis by identifying software failure modes
• Maintain traceability between requirements, code and tests
• Investigate and resolve defects through the formal process
• Support verification and validation activities
• Contribute to design history file documentation
• Work with hardware and systems engineers on integration
• Follow change control and configuration management procedures

Education

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

Required Skills and Experience

• 2+ years of software development, ideally in a regulated environment
• Proficiency in C, C++ or another language used in device software
• Willingness to work within a documented quality process
• Understanding of software testing and its documentation
• Ability to write clear technical documentation
• Attention to detail and comfort with traceability requirements
• Familiarity with version control and change management
• Collaborative approach with quality and systems teams

Preferred Qualifications

• Exposure to IEC 62304
• Embedded systems experience