Medical Device Software Engineering Lead

DEKA Research & Development is seeking a Medical Device Software Engineering Lead to join our team. This is a hands-on technical leadership role responsible for both the architecture and delivery of software for a complex FDA-regulated medical device. Youll work across every layer of the stack embedded device drivers and real-time control loops Android-based UI and cloud connectivity for data exchange while leading a team of engineers through a structured regulated development process from design through release.

This is an on-site role; remote and hybrid are not available.

• Own and drive software architecture technical direction and key design decisions across embedded Android and cloud layers
• Design implement and verify medical device software with a strong focus on reliability performance and maintainability
• Lead a team of engineers setting cadence (planning standups reviews) and holding the team accountable for progress and quality
• Plan releases and maintain status against them ensuring all required inputs (features bug fixes) are complete and testing is properly defined and passing before release
• Lead technical reviews (design architecture and code) and mentor junior engineers in both technical practice and ways of working
• Solve complex system-level problems across hardware and software boundaries partnering closely with electrical mechanical and biomedical engineering
• Define analyze and maintain software requirements interfaces and development procedures within our FDA design-controls process
• Perform software risk and failure mode analysis in accordance with ISO 14971 and ensure lifecycle activities align with IEC 62304
• Develop and verify software test procedures to confirm requirements are met

Skills you will need to be successful:

• Bachelors degree in Computer Science or equivalent work experience and 5 years of relevant experience
• Proven experience as a technical lead or go-to software engineer designing and implementing software/hardware systems for medical devices or other safety-critical regulated products
• Demonstrated experience leading or mentoring junior engineers
• RTOS and embedded systems development experience (e.g. FreeRTOS embedded Linux or similar safety-critical platforms)
• 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 and medical device software standards (e.g. IEC 62304 ISO 14971) preferred
• Strong troubleshooting skills and ability to adapt rapidly to changing circumstances and technology
• Excellent communication skills and attention to detail with a genuine desire to teach and help others succeed
• Controls engineering experience beneficial but not required

About DEKA:

One hour from the beach Boston and the mountains the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development where we are taking the same innovation and cutting-edge technology into the modern age.

Behind DEKAs brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering design and manufacturing. Here at DEKA some of the most innovative and life-changing products of our time are created and new ideas are always welcome and explored.

Required Experience:

Manager