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. You'll 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. How you will make an impact: Own and drive software architecture, technical direction, and key design decisions across embedded, Android, and cloud layersDesign, implement, and verify medical device software with a strong focus on reliability, performance, and maintainabilityLead a team of engineers, setting cadence (planning, standups, reviews) and holding the team accountable for progress and qualityPlan releases and maintain status against them, ensuring all required inputs (features, bug fixes) are complete and testing is properly defined and passing before releaseLead technical reviews (design, architecture, and code) and mentor junior engineers in both technical practice and ways of workingSolve complex system-level problems across hardware and software boundaries, partnering closely with electrical, mechanical, and biomedical engineeringDefine, analyze, and maintain software requirements, interfaces, and development procedures within our FDA design-controls processPerform software risk and failure mode analysis in accordance with ISO 14971, and ensure lifecycle activities align with IEC 62304Develop and verify software test procedures to confirm requirements are met Skills you will need to be successful: Bachelor's degree in Computer Science or equivalent work experience, and 5+ years of relevant experienceProven experience as a technical lead or go-to software engineer designing and implementing software/hardware systems for medical devices or other safety-critical, regulated productsDemonstrated experience leading or mentoring junior engineersRTOS and embedded systems development experience (e.g., FreeRTOS, embedded Linux, or similar safety-critical platforms)Experience with Android application developmentExperience defining software requirements and architecture for large, multi-component software systemsExperience developing and verifying software test procedures against defined requirementsFamiliarity with FDA design controls and medical device software standards (e.g., IEC 62304, ISO 14971) preferredStrong troubleshooting skills and ability to adapt rapidly to changing circumstances and technologyExcellent communication skills and attention to detail, with a genuine desire to teach and help others succeedControls 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.