Senior Software Engineer (Medical Devices) Job Description Template

The senior software engineer in medical devices takes design ownership of significant software components and carries responsibility for the quality record behind them. Beyond the technical work, the role is expected to guide less experienced engineers through a development process that is genuinely different from commercial software, where the documentation and the traceability are part of the product rather than a formality afterwards.

Typical Duties and Responsibilities

• Own the design and implementation of major software components
• Write architecture and detailed design documentation to regulatory standard
• Lead software risk analysis and define mitigations
• Review code and design work from other engineers
• Define verification strategy and review test protocols
• Mentor engineers on both the technical work and the quality process
• Support regulatory submissions with the software documentation package
• Investigate field issues and lead root cause analysis
• Evaluate third party software for use within the device
• Contribute to process improvement within the quality system

Education

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

Required Skills and Experience

• 6+ years of medical device software development
• Deep familiarity with IEC 62304 and ISO 14971 in practice
• Strong C or C++ and experience with the relevant device platform
• Track record of software work included in a successful regulatory submission
• Ability to write design documentation that withstands audit
• Experience leading verification activities
• Mentoring and code review experience
• Understanding of post market surveillance obligations

Preferred Qualifications

• Experience with Class III devices
• Familiarity with cybersecurity expectations for connected devices