Lead Software Engineer - medical device

InnoTech Staffing • Manchester, NH

1d • Onsite

About The Position

InnoTECH Staffing is seeking a hands-on technical leader to guide development of a complex, FDA-regulated medical device. The role owns software architecture and technical direction across embedded device drivers, real-time control systems, Android applications, and cloud connectivity, and contributes directly to engineering work throughout the development lifecycle, from initial design through final release. The position is fully onsite in Manchester, New Hampshire; remote and hybrid arrangements are not available.

The Lead Software Engineer will guide a team of software engineers, shape architecture and design decisions, mentor team members, and drive release planning and execution. The role works closely with electrical, mechanical, and biomedical engineering teams to address hardware-software integration challenges. It also leads requirements definition, software risk assessments, verification activities, and development practices within FDA design controls and applicable medical-device software standards.

Requirements

• Bachelor's degree in Computer Science or equivalent professional experience.
• At least 5 years of relevant software engineering experience.
• 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.
• Strong problem-solving ability and willingness to engage with complex technical details.
• Strong communication skills, including translating technical concepts into clear direction and actionable decisions.
• Collaborative leadership approach, with an interest in sharing knowledge, mentoring others, and helping engineers grow.
• Ability to adapt in a dynamic environment as challenges, priorities, and technologies evolve.
• Exceptional attention to detail and commitment to engineering quality.

Nice To Haves

• Familiarity with FDA design controls and medical device software standards, including IEC 62304 and ISO 14971.
• Controls engineering experience.

Responsibilities

• Own software architecture, technical strategy, and critical design decisions across embedded systems, Android applications, and cloud connectivity.
• Design, develop, and verify medical device software with a focus on reliability, performance, scalability, and maintainability.
• Guide software engineers, establish an effective development rhythm, drive accountability, and foster an environment where engineers can thrive.
• Plan and execute releases, track progress, manage priorities, and ensure features, fixes, and verification activities are ready for each release.
• Lead architecture, design, and code reviews; mentor engineers and promote strong engineering practices.
• Solve system-level hardware-software challenges in collaboration with electrical, mechanical, and biomedical engineering teams.
• Define and maintain software requirements, interfaces, and development procedures within an FDA design-controls framework.
• Lead software risk assessments and failure mode analysis in accordance with ISO 14971, and ensure software lifecycle activities align with IEC 62304.
• Develop and verify software test procedures to demonstrate that requirements are met and the product performs as intended.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior