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)
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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