Principal Software Development Engineer (Embedded)

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. Employee Benefit: Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA Dental Vision Healthcare Flexible Spending Account Dependent Care Flexible Spending Account Short Term Disability Long Term Disability 401K Plan Pet insurance Employee Stock Purchase Plan 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. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. – aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.