Medical Device Software Engineering Lead

DEKA Research & Development•Manchester, NH
•Onsite

About The Position

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.

Requirements

  • 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
  • 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

Nice To Haves

  • Familiarity with FDA design controls and medical device software standards (e.g., IEC 62304, ISO 14971) preferred
  • Controls engineering experience beneficial but not required

Responsibilities

  • 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
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