Principal Software Engineer

Transcend, Inc. is a fast-growing, Twin Cities–based medical device company that is transforming the way people experience sleep therapy. Our flagship travel-friendly CPAP device—small enough to fit in the palm of your hand—along with an expanding ecosystem of accessories, helps people sleep better, travel easier, and live more fully wherever their journey takes them.

Our mission is simple but powerful:
We help people live happy and healthy lives through better sleep.

We are seeking a Principal Software Engineer to lead the architecture, design, and development of software for a connected Class II medical device, including embedded firmware, mobile applications, and cloud-connected Software-as-a-Medical-Device (SaMD) components.

This role combines hands-on technical leadership with software design assurance, ensuring compliance with FDA design controls while delivering safe, reliable, and high-performance systems that directly impact patient therapy. You will drive system architecture decisions, guide software lifecycle processes, and integrate risk management principles across all development stages, and collaborate with UX/UI designers to shape intuitive, patient-centered experiences across mobile and connected device interfaces.

The ideal candidate brings deep experience in regulated, safety-critical environments and demonstrates expertise in IEC 62304, ISO 14971, and FDA 21 CFR Part 820, along with a strong ability to lead cross-functional engineering efforts.

• Design, develop, and implement the system and software architecture for a connected CPAP platform spanning embedded firmware, mobile applications, and cloud-based components
• Drive end-to-end software lifecycle execution in compliance with IEC 62304
• Own integration of risk management practices (ISO 14971) into software design and development decisions
• Lead cross-functional collaboration with Engineering, Quality, Regulatory Affairs, and Operations
• Lead design reviews, code reviews, and formal risk analyses (FMEA, fault tree analysis)
• Establish and enforce best practices for software verification, validation, and design documentation
• Author and support software deliverables for regulatory submissions (e.g., 510(k))
• Lead investigation and resolution of software-related nonconformances, CAPAs, and field issues

• Bachelor’s degree in technical or scientific discipline
• 8+ years of software development experience, including work in regulated industries
• Hands-on experience performing bench-level testing and verification of embedded software, including setup and execution of test fixtures, simulators, hardware interfaces, and diagnostic tools to validate functional, performance, and integration requirements
• Proficiency in one or more programming languages (e.g., C/C++, Python, Java)
• Experience with embedded systems, real-time systems, or connected medical devices
• Strong understanding of requirements management, traceability, and verification strategies
• Excellent communication and cross-functional collaboration skills
• Thrives in a fast-paced, small-company environment where ownership is real, decisions move fast, and doing it right matters

• Hands-on experience with IEC 62304-compliant software development processes
• Experience applying ISO 14971 risk management principles to software systems
• Experience with FDA software guidance, cybersecurity guidance, and global regulatory expectations
• Experience with software risk management tools
• Experience using defect tracking and requirements management tools
• Experience with mobile application–based products
• Experience with connected medical devices and cloud-connected applications
• Familiarity with UX/UI design principles and experience collaborating with UX designers to deliver intuitive, patient-centered interfaces for mobile or connected device applications