Senior Software Engineering Manager, Embedded Systems

Job Description:

Position Summary

We are seeking a Senior Software Engineering Manager, Embedded Systems, to lead the team building embedded software for the Organ Care System (OCS). You will manage full-time and contract engineers, own program schedules and milestones, and ensure compliance with our engineering processes and medical device standards.

TransMedics, Inc. is transforming solid organ transplantation for patients with end-stage heart, lung, and liver failure. Our OCS Heart, Lung, and Liver systems hold U.S. PMA approvals and CE Marks. This position is onsite 5 days a week.

Responsibilities

• Lead, hire, and develop a team of full-time and contract embedded software engineers.
• Manage contractors and vendors, including SOWs, deliverables, and performance.
• Build and own program plans, schedules, milestones, and resource allocation; report status and risks to leadership.
• Ensure the team follows the software lifecycle per FDA guidance, IEC 62304, ISO 13485, and ISO 14971.
• Own software development, verification, and configuration management procedures and DHF deliverables.
• Lead software risk management, field complaint investigations, and CAPA.
• Support quality audits, FDA inspections, and regulatory submissions.
• Provide technical direction on embedded architecture, design, and code quality.
• Partner with Systems, Hardware, Quality, Regulatory, and Product teams on requirements and integrated timelines.
• Perform other TransMedics tasks and duties as assigned/required.

Management Responsibilities

This position manages full-time and contract embedded software engineers.

Minimum Qualifications

• BS/MS in Software Engineering, Electrical Engineering, or equivalent.
• 8+ years in real-time embedded software development.
• 5+ years managing embedded software teams, including contractors or vendors.
• Proven record delivering products and managing program schedules and milestones.
• Medical device or regulated-industry software experience (IEC 62304, FDA, ISO 13485).

Preferred Qualifications

• Class II/III medical device experience, including PMA or 510(k) submissions.
• Embedded architecture expertise in C/ C++, RTOS (e.g., QNX) and ARM/ PIC platforms.
• Familiarity with CI/CD, static analysis, and medical device cybersecurity.
• Agile experience within a design-controlled environment.
• PMP or similar certification, a plus.
• Strong communication and organizational skills.

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.