Senior Software Engineer

Metric Bio is working with a medical device company that is bringing more of its software development in-house. The Senior Software Engineer will take hands-on ownership of embedded Linux development, hardware and sensor integration, software architecture, testing and verification, and software processes in an FDA-regulated environment.

Responsibilities:

• Embedded Linux development and upgrades to the existing platform
• Software architecture and requirements
• Hardware and sensor integration
• Integrating third-party devices and APIs
• Software V&V and integration testing
• IEC 62304 processes and documentation
• Configuration management and revision control
• Software risk management
• Cybersecurity risk analysis and FDA cybersecurity requirements
• Supporting the transition of software knowledge from external partners and consultants in-house

Requirements:

• You'll need a strong software engineering background within medical devices or another highly regulated environment
• Embedded Linux
• IEC 62304
• FDA-regulated software development
• Software V&V
• Cybersecurity
• Software architecture and requirements
• Hardware/software integration
• Software risk management
• You'll need to be comfortable working hands-on with the software while also owning the processes and documentation around it
• Experience with IVD products, spectrometers or optical systems, Yocto, Ubuntu or bare-metal firmware