Lead Software Engineer - medical device

Job Description

Job Description

InnoTECH Staffing is looking for an exceptional Medical Device Software Engineering Lead to take on a career-defining opportunity at the intersection of advanced technology, engineering innovation, and healthcare.

This is your opportunity to lead the development of sophisticated, life-impacting medical device technology while remaining hands-on with the engineering challenges that make it all possible.

We're looking for a technical leader who loves solving complex problems, building great software, and inspiring engineering teams to deliver their best work. You'll own the software architecture and technical direction of a complex, FDA-regulated medical device, guiding development across the entire technology stack — from embedded device drivers and real-time control systems to Android-based user interfaces and cloud connectivity.

You'll have the opportunity to influence major architectural decisions, tackle challenging hardware-software integration problems, mentor talented engineers, and drive a product through every stage of the development lifecycle — from initial design to final release.

This is much more than a software management position. It's a hands-on technical leadership role where your engineering expertise, vision, and leadership will directly shape the technology being brought to market.

Please note: This is a fully on-site opportunity in Manchester, NH. Remote and hybrid arrangements are not available.

How You'll Make an Impact

You'll be at the center of the software engineering effort, driving technical excellence, team performance, and product success.

• Own the Technology Vision: Lead software architecture, technical strategy, and critical design decisions across embedded systems, Android applications, and cloud connectivity.
• Build Innovative Solutions: Design, develop, and verify sophisticated medical device software with a relentless focus on reliability, performance, scalability, and maintainability.
• Lead and Inspire: Guide a team of software engineers, establish an effective development rhythm, drive accountability, and create an environment where engineers can thrive.
• Drive Successful Releases: Own release planning and execution, track progress, manage priorities, and ensure features, fixes, and verification activities are ready before each release.
• Raise the Engineering Bar: Lead architecture, design, and code reviews while mentoring engineers and promoting strong engineering practices.
• Tackle Complex Engineering Challenges: Solve challenging system-level problems at the intersection of hardware and software, collaborating closely with electrical, mechanical, and biomedical engineering teams.
• Champion Quality and Compliance: Define and maintain software requirements, interfaces, and development procedures within an FDA design-controls framework.
• Manage Software Risk: Lead software risk assessments and failure mode analysis in accordance with ISO 14971 and ensure software lifecycle activities align with IEC 62304.
• Deliver with Confidence: Develop and verify software test procedures to demonstrate that requirements are met and the product performs as intended.

What You'll Bring to the Team

We're looking for a technically strong engineer who is ready to take ownership, influence decisions, and help a team accomplish something meaningful.

Your Experience & Technical Expertise

• Bachelor's degree in Computer Science or equivalent professional experience.
• 5+ years of relevant software engineering experience.
• Proven experience as a technical lead or go-to engineer designing and developing complex software/hardware systems for medical devices or other safety-critical, regulated products.
• Demonstrated success leading, mentoring, or developing junior engineers.
• Hands-on experience with RTOS and embedded systems development, such as FreeRTOS, embedded Linux, or comparable platforms.
• Experience developing Android applications.
• Strong background 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, including IEC 62304 and ISO 14971, is highly desirable.

The Qualities That Will Set You Apart

• A natural problem-solver who enjoys getting into the details of complex technical challenges.
• A strong communicator who can translate technical concepts into clear direction and actionable decisions.
• A collaborative leader who enjoys sharing knowledge, mentoring others, and helping engineers grow.
• Someone who thrives in a dynamic environment and can adapt quickly as challenges, priorities, and technologies evolve.
• Exceptional attention to detail and a commitment to engineering quality.
• Controls engineering experience is a plus, but not required.

Why This Opportunity?

Because you won't simply be maintaining an existing product or managing a development schedule.

You'll be shaping the architecture of a sophisticated medical device, leading the engineers who bring it to life, and working across an exciting range of technologies. You'll have the technical ownership to make meaningful decisions, the opportunity to solve problems that truly challenge your engineering abilities, and the satisfaction of contributing to technology designed to make a difference in healthcare.

If you're a hands-on engineering leader who loves complex technology, thrives on solving difficult problems, and is ready to make a meaningful impact, we'd love to hear from you!

Take the lead. Build something extraordinary.

This role is onsite in Manchester, New Hampshire