Company Overview
We are partnering with an innovative organization in the medical device industry dedicated to developing life-sustaining technologies that improve patient outcomes and quality of care. The company operates in a highly regulated environment where safety, precision, and reliability are critical to success. Their culture emphasizes accountability, technical excellence, and cross-functional collaboration to deliver impactful solutions.
Role Summary
The Manager, Software Engineering is a hands-on technical leadership role responsible for driving the end-to-end development of embedded software and firmware for a complex medical device platform. This individual will play a key role in shaping architecture, guiding engineering execution, and ensuring delivery of high-quality, compliant software solutions.
This role combines technical depth with leadership, requiring approximately 30–50 percent hands-on involvement in coding, reviews, debugging, and system design. The position will lead both new platform development and sustaining engineering efforts, while introducing structure, discipline, and best practices across the software team. Success will require strong collaboration across Quality, Regulatory, hardware, and clinical stakeholders.
Key Responsibilities
• Lead end-to-end software and firmware development across the full lifecycle from requirements through release and sustaining
• Drive software architecture, interface design, and system behavior across sensors, controls, alarms, and user interface components
• Participate directly in code reviews, debugging, defect triage, and technical decision making
• Establish engineering discipline including traceability, documentation quality, and review rigor in a regulated environment
• Translate user needs, clinical workflows, and system requirements into clear and testable software requirements
• Own sustaining engineering efforts including investigations, root cause analysis, CAPAs, and reliability improvements
• Partner cross-functionally with Quality, Regulatory, hardware, manufacturing, and clinical teams to deliver compliant solutions
• Build and lead a high-performing engineering team while coaching developers on quality and best practices
Key Requirements
• Eight or more years of experience in embedded software or firmware development including regulated product environments
• Three or more years of experience leading engineering teams or major technical programs with direct delivery responsibility
• Strong programming expertise in C# with exposure to embedded systems and Linux environments
• Demonstrated experience delivering software in medical device, aerospace, or other highly regulated industries
• Deep understanding of design controls, FDA expectations, traceability, risk management, and verification practices
• Experience working across full software lifecycle including architecture, development, integration, testing, and release
• Strong problem solving skills with the ability to operate hands on in debugging and system level issues
• Excellent communication and collaboration skills with the ability to influence cross-functional teams
Call to Action
If you are a hands-on engineering leader who thrives in regulated environments and enjoys driving both technical execution and team performance, we encourage you to apply. Please submit your resume and contact information to be considered for this impactful opportunity.
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