Senior Staff Software Engineer

The Senior Staff Software Engineer is a hands-on technical contributor responsible for developing software and technical solutions for embedded electro-mechanical medical devices, supporting innovation, new product development, and sustaining engineering across UCC's Acute Care, Home Care, Targeted Temperature Management, and Endourology portfolios. The role partners with cross-functional engineering teams to translate customer, clinical, business, and regulatory needs into safe, reliable, maintainable, and testable software solutions.

The individual contributes throughout the software development lifecycle, including architecture, requirements, design, implementation, integration, verification, release, maintenance, and problem resolution. Solutions must comply with applicable international regulatory requirements and BD quality system expectations, including IEC 62304 and other standards relevant to the product.

The ideal candidate combines strong embedded software expertise, technical depth, systems thinking, analytical problem-solving, and effective communication skills. They are capable of independently driving complex technical initiatives, influencing technical decisions, mentoring engineers, and communicating risks, tradeoffs, and recommendations to both technical and non-technical stakeholders. They thrive in a global matrix environment and collaborate effectively across disciplines to deliver high-quality software products.

Responsibilities

• Serve as a senior technical contributor supporting innovation, new product development, and sustaining engineering for embedded electro-mechanical medical devices across UCC platforms.
• Lead or substantially contribute to software architecture, requirements, detailed design, implementation, integration, debugging, code reviews, testing, and technical decision-making.
• Develop and maintain embedded software and firmware solutions, including RTOS-based applications, hardware-software interfaces, communication protocols, device drivers, diagnostics, fault handling, firmware updates, and other platform-level software components as applicable.
• Translate user needs, product requirements, system requirements, and risk controls into clear, testable software requirements and design solutions.
• Apply regulated software-development practices throughout the product lifecycle, including design controls, software risk management, traceability, verification, configuration management, change control, release management, and problem resolution.
• Create and maintain software lifecycle deliverables, including plans, requirements, architecture and design documentation, source code, reviews, test evidence, anomaly records, risk-control evidence, and release documentation.
• Collaborate with cross-functional partners including Marketing, Systems, Electrical, Mechanical, Quality, Regulatory Affairs, Human Factors, Verification & Validation, Cybersecurity, Operations, Service, and external development partners.
• Support product complaints, field issues, software anomalies, audits, regulatory submissions, and complex system-level investigations.
• Contribute to connected-device and companion application solutions, including device connectivity, secure data exchange, deployment, cybersecurity, and lifecycle maintenance.
• Utilize approved AI-assisted development tools to support software development, documentation, testing, refactoring, and troubleshooting activities while maintaining appropriate engineering review and accountability.
• Mentor engineers, promote technical excellence, improve development practices, and effectively communicate risks, tradeoffs, recommendations, and technical concepts to diverse stakeholders.

• Bachelor's degree in Software Engineering, Computer Science, Computer Engineering, Electrical Engineering or related technical discipline.
• 8+ years of professional software development experience.
• Experience developing software for medical devices or other regulated, safety-critical products.
• Experience developing software within a controlled product lifecycle, including requirements, architecture, design, implementation, verification, configuration management, change control, documentation, and problem resolution.
• Strong embedded software development experience, including proficiency in C/C++, RTOS environments, microcontrollers or processors, hardware-software interfaces, communication protocols, debugging, testing, integration, and system-level troubleshooting.
• Working knowledge of design controls, software risk management, requirements traceability, verification activities, and IEC 62304 or equivalent regulated software lifecycle standards.

• Master's degree in Software Engineering, Computer Science, Computer Engineering, Electrical Engineering or related technical discipline.
• Experience developing, integrating, testing, or maintaining mobile or companion-device applications.
• Experience with embedded Linux, connected-device architectures, platform modernization, or software architecture migration initiatives.
• Experience with Bluetooth Low Energy (BLE), Wi-Fi, Ethernet, APIs, cloud integration, telemetry, remote diagnostics, or medical-device cybersecurity.
• Experience with ISO 13485, ISO 14971, CI/CD, static analysis, automated regression testing, Hardware-in-the-Loop (HIL), or Software-in-the-Loop (SIL) test environments.
• Experience using AI-assisted software-development tools such as GitHub Copilot, Claude Code, OpenCode, or similar technologies.