Medical Device Software Engineering Lead
DEKA Research and Development Corporation1 month ago
Manchester, NH, USAStaff+
Responsibilities
- Own software architecture, technical direction, and key design decisions across embedded, Android, and cloud layers.
- Design, implement, and verify reliable, performant, and maintainable medical device software.
- Lead and mentor engineers while establishing planning, review, and accountability practices.
- Plan releases, track status, and ensure features, bug fixes, and testing are complete before release.
- Lead design, architecture, and code reviews and mentor junior engineers.
- Solve system-level problems across hardware and software in partnership with electrical, mechanical, and biomedical engineers.
- Define and maintain software requirements, interfaces, and development procedures within the FDA design-controls process.
- Perform software risk and failure mode analysis in accordance with ISO 14971 and align lifecycle activities with IEC 62304.
- Develop and verify software test procedures against defined requirements.
Requirements
- Bachelor's degree in Computer Science or equivalent work experience.
- 5+ years of relevant experience.
- Experience as a technical lead or go-to software engineer designing and implementing software and hardware systems for medical devices or other safety-critical, regulated products.
- Experience leading or mentoring junior engineers.
- RTOS and embedded systems development experience, such as FreeRTOS or embedded Linux.
- Experience with Android application development.
- Experience defining software requirements and architecture for large, multi-component software systems.
- Experience developing and verifying software test procedures against defined requirements.
- Familiarity with FDA design controls, IEC 62304, and ISO 14971 is preferred.
- Strong troubleshooting, adaptability, communication, attention to detail, and mentoring skills.
- Controls engineering experience is beneficial but not required.
Benefits
- Fully on-site role; remote and hybrid work are not available.
- Located in the historic Amoskeag Millyard, approximately one hour from the beach, Boston, and the mountains.
Categories
EmbeddedMobile
About DEKA Research and Development Corporation
DEKA Research & Development Corporation is a privately held R&D firm that invents and develops medical devices, robotics, and manufacturing systems for healthcare and technology partners. Founded in 1982 by Dean Kamen and headquartered in Manchester, NH, it typically licenses or transfers its designs to external manufacturers for mass production. Notable projects include the iBOT stair-climbing mobility system and the LUKE prosthetic arm supported by DARPA.