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About the role
- Principal Software Developer at Cognixion responsible for software delivery for medical devices. Leading technical teams and ensuring compliance with regulatory standards in a hybrid setting.
Responsibilities
- Direct management of a 2-3 software developers
- Design, implement and maintain production quality software components across one or more target environments (embedded Linux, Apple Vision Pro, Android, etc.)
- Leads technical decision-making for assigned systems or subsystems
- Executes software development activities in compliance with applicable medical device SDLC expectations, including creation of design artifacts such as risk analysis, requirements, test reports
- Builds automated tests, improves testability and ensures sufficient test coverage to support regulatory submissions and system reliability
- Mentors developers through pairing, design reviews, debugging support and guidance on regulated documentation and testing practices
- Provides clear status updates, identifies risks early and proposes mitigation plans
Requirements
- Bachelor’s degree in computer science, Software Engineering, Computer Engineering is required
- 10+ years of progressive software development experience
- Demonstrated experience shipping Software as a Medical Device (SaMD) and/or Software in a Medical Device (SiMD)
- Prior experience in scientific computing preferred (signal processing, numerical methods, ML/AL, etc.)
- Embedded Linux development and/or AR/VR (e.g. Unity) experience preferred
- Strong understanding of modern engineering practices: architecture and design patterns, CI/CD, automated testing strategies, code review culture, and secure coding
- Excellent communication skills with the ability to translate between technical and non-technical stakeholders and to produce clear, audit-ready technical documentation
- Experience integrating software with wearable sensors, BLE peripherals, or custom hardware (drivers, protocols, data integrity) preferred
- Familiarity with medical device software standards and expectations (e.g., IEC 62304, IEC 82304-1, ISO 14971, FDA software guidance, cybersecurity/SBOM concepts) required
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