Medical Device Software Engineering Lead

DEKA Research & Development Corp.; Manchester (NH); On-site; USD 140,000 - 190,000; Full time

Job summary

DEKA Research & Development Corp. seeks a Medical Device Software Engineering Lead to own architecture and delivery of software for a regulated medical device. You will drive embedded, Android, and cloud layers while leading engineers through a design‑to‑release process in an on‑site setting.

The role requires a strong background in RTOS/embedded systems, Android development, and FDA/IEC design controls, with proven leadership and mentoring capabilities to guide a high‑performing team.

Qualifications

• Bachelor's degree in Computer Science or equivalent and 5+ years of relevant experience.
• Experience designing and delivering software for medical devices or safety-critical products.
• Demonstrated ability to lead or mentor engineers.

Responsibilities

• Own software architecture across embedded, Android, and cloud layers.
• Design, implement, and verify medical device software for reliability and performance.
• Lead a team, plan releases and maintain progress against schedules.
• Lead technical reviews and mentor junior engineers.
• Collaborate across hardware, mechanical, and biomedical teams.
• Define software requirements and FDA/IEC design-control processes.
• Develop and verify software test procedures to ensure requirements are met.

Skills

Technical leadership

RTOS & Embedded

Android development

Software requirements

Software testing

Regulatory standards

Mentoring

Communication skills

Education

Bachelor's degree in Computer Science or equivalent

Tools

FreeRTOS

Embedded Linux

Android

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.