Medical Device Software Engineering Lead

DEKA Research and Development; Manchester (NH); On-site; USD 150,000 - 230,000; Full time

Job summary

DEKA Research & Development is seeking a Medical Device Software Engineering Lead to guide architecture and delivery for a complex FDA-regulated device. This hands-on leadership role spans embedded drivers, Android UI, and cloud data exchange.

On-site role with no remote or hybrid options. You will lead engineers, plan releases, and ensure compliance with FDA design controls and IEC 62304/ISO 14971 while mentoring peers and driving robust software practices.

Qualifications

• Bachelor's degree in Computer Science or equivalent.
• 5+ years of relevant experience in medical devices or safety-critical, regulated products.
• Experience as a technical lead or mentor to other engineers.
• RTOS/embedded systems development experience (FreeRTOS or embedded Linux).
• Experience with Android application development and system-level architecture.
• Familiarity with FDA design controls and IEC 62304 / ISO 14971.

Responsibilities

• Own and drive software architecture across embedded, Android, and cloud layers.
• Design, implement, and verify medical device software with focus on reliability and maintainability.
• Lead a team of engineers: cadence, planning, standups, reviews, and progress tracking.
• Plan releases and ensure features and bug fixes are defined and tested before release.
• Lead design, architecture, and code reviews and mentor junior engineers.
• Solve complex system-level problems across hardware and software boundaries with cross-discipline partners.
• Define, analyze, and maintain software requirements and interfaces within FDA design-controls.
• Perform software risk and failure mode analysis per IEC 62304 and ISO 14971.
• Develop and verify software test procedures to ensure requirements are met.

Skills

Technical leadership

Embedded systems

Android development

Software architecture

Software testing

Troubleshooting

Communication

Mentoring

Education

Bachelor's degree in Computer Science

Tools

FreeRTOS

embedded Linux

Android SDK

Job description

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 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:

• 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.