Medical Device Software Engineering Lead

DEKA Research & Development; Manchester (NH); On-site; USD 150,000 - 190,000; Full time

Job summary

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

You will mentor engineers, drive releases, and ensure IEC 62304/ISO 14971 compliance for reliable, high-performance software across multi-domain systems, collaborating with electrical, mechanical, and biomedical teams in a

Qualifications

• Bachelor's degree in Computer Science or equivalent work experience.
• 5+ years of relevant experience in medical device software or safety-critical, regulated products.
• Proven experience as a technical lead or mentor for engineers.

Responsibilities

• Own and drive software architecture across embedded, Android, and cloud layers.
• Design, implement, and verify medical device software prioritizing reliability and performance.
• Lead a team of engineers, plan cadences, reviews, and ensure on-time delivery.
• Plan releases with complete features and testing definitions.
• Lead design, architecture, and code reviews and mentor junior engineers.
• Collaborate with electrical, mechanical, and biomedical teams to resolve complex system issues.
• Define and maintain software requirements and interfaces within FDA design-controls.

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.