Medical Device Software Engineering Lead

• 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

• Bachelor's 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 DEKA's 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.