Director, Embedded Software Development

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The Director, Embedded Software Development in the medical device industry is a hands-on technical leadership role responsible for guiding day-to-day firmware and embedded software development while actively contributing to design, implementation, debugging, testing, and compliance activities. This role requires deep technical expertise in real-time systems, practical experience with safety-critical software, and working knowledge of standards such as IEC 62304 and FDA 21 CFR Part 820.

The Director, Embedded Software Development will lead an embedded software/firmware engineering team while remaining closely involved in technical execution. The position requires collaborating with hardware, software, systems, quality, and manufacturing teams to deliver reliable medical device software from concept through verification, release, and sustaining support.

Technical Execution: Contribute directly to embedded software design, implementation, tool evaluation and selection, code reviews, debugging, integration, and verification activities for medical device products.

Team Leadership & Mentoring: Provide day-to-day technical direction, coaching, and task prioritization for embedded software engineers while fostering strong engineering practices and collaboration.

Regulatory Compliance & Quality: Support compliance with FDA, ISO 13485, and IEC 62304 standards by producing and reviewing software development plans, requirements, design documentation, traceability, verification evidence, and release records.

Embedded Design & Architecture: Develop and guide C/C++ embedded software in Linux/RTOS environments, including drivers, hardware interfaces, control algorithms, diagnostics, and system-level integration.

Test & Troubleshooting: Support bench testing, target testing and debugging, hardware/software integration, defect investigation, and root-cause analysis in collaboration with engineering and quality teams.

Cross-Functional Collaboration: Work closely with hardware, systems, applications, product management, manufacturing, and clinical teams to resolve technical issues and ensure embedded software meets product and user needs.

Risk & Cybersecurity: Participate in software risk analysis, cybersecurity threat modeling, hazard mitigations, and verification planning in partnership with systems, quality, and cybersecurity teams.

Project Coordination: Help plan sprint work, track progress, manage technical dependencies, and communicate execution risks while maintaining focus on hands-on delivery.

Education: Engineering degree in Computer Science, Electrical Engineering, or related technical field.

Experience: 10+ years in embedded software development, with experience in regulated environments; medical device experience strongly preferred.

Leadership: 4+ years of experience providing technical leadership, mentoring engineers, or managing small software teams while remaining engaged in hands-on development.

Technical Skills: Strong hands-on proficiency in C/C++ in Linux and/or RTOS environments, with practical experience developing low-level drivers, hardware interfaces, diagnostics, and embedded application software.

Regulatory Knowledge: Working knowledge of IEC 62304, ISO 14971, and FDA software validation expectations, including requirements, traceability, verification, and release documentation.

Travel to vendor and customer sites may be required on an as needed basis.

Experience with CI/CD Build Pipelines and target testing methodologies for medical devices.

Expertise in cybersecurity protocols and safety-critical system development.

Proven ability to work with external vendors and partners as required.

Excellent communication skills, with the ability to convey technical concepts to non-technical stakeholders.