Principal Software Developer
The Software Team Lead drives the hands-on implementation and delivery of software for Cognixion’s medical device and research platforms. This role provides technical leadership to ensure solutions are robust, testable, and compliant, while contributing directly to design, coding, integration, verification, and release activities within a regulated software development lifecycle.
Duties and 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.
Qualifications
- Bachelor’s degree in computer science , Software Engineering, Computer Engineering is .
- 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) .
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