Medical Device Software Engineer Job Description Template

The medical device software engineer writes software that runs in or alongside a regulated medical device, which means the code is governed by a quality system and every design decision has to be traceable to a requirement. The engineering itself is often embedded or safety critical, and the surrounding documentation is not optional overhead, since it is what allows the device to be cleared for sale and defended afterwards.

Typical Duties and Responsibilities

• Develop software for medical devices under a controlled design process
• Write and maintain software requirements traceable to system requirements
• Implement software in line with IEC 62304 lifecycle expectations
• Perform and document unit, integration and system level testing
• Contribute to risk analysis and implement the resulting mitigations
• Participate in design reviews and formal verification activities
• Maintain design history documentation for regulatory submission
• Investigate defects and support corrective and preventive action processes
• Work with quality and regulatory colleagues throughout development
• Support software of unknown provenance evaluation for third party components

Education

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

Required Skills and Experience

• 3+ years of software engineering in a regulated medical device environment
• Working knowledge of IEC 62304 and the software safety classifications
• Strong C, C++ or another language appropriate to the device platform
• Experience with requirements traceability and design controls
• Understanding of risk management under ISO 14971
• Disciplined documentation habits under a quality management system
• Experience with verification and validation testing
• Ability to work within formal change control

Preferred Qualifications

• Experience with an FDA submission or CE marking
• Background in embedded or real time systems