Senior Director, Systems Engineering

Job Description:

TransMedics is transforming organ transplant therapy with the Organ Care System (OCS)—the first portable warm-perfusion platform that keeps donor organs functioning outside the body. It's technology built to give more patients a chance at a transplant, and more transplant teams the confidence to say yes to an organ they'd otherwise might  turn away.

The Sr. Director of Systems Engineering owns the system-level architecture, requirements, and verification strategy that ties electrical, mechanical, and software design together into a single working device—one that has to perform flawlessly with an organ inside it. This is a senior leadership role with a seat on the R&D leadership staff, driving the long-range technical strategy across next-generation Organ Care Systems.

This is a build role, not a maintain role. As the OCS platform grows more capable and TransMedics scales, systems engineering needs a leader who can set the multi-year architecture strategy and organizational capability plan—while staying close enough to translate system requirements into subsystem requirements personally when a program is under pressure. We're looking for someone equally comfortable owning the technical roadmap and driving detailed execution when it counts.

• Set department strategy — define the strategy for Systems Engineering within R&D, including the capabilities needed for TransMedics future.
• Own system architecture — lead overall system architecture, requirements definition, design, and testing for next-generation Organ Care Systems, ensuring compliance with regulatory standards. This includes system-level performance of electro-mechanical and software systems, accounting for clinical needs and human factors, and translating system requirements into subsystem design requirements.
• Lead design teams — provide leadership, oversight, and guidance to internal and external design teams for new products.
• Stay hands-on — bring a hands-on approach to systems engineering strategy, driving detailed execution of requirements definition through design translation, verification, and validation.
• Lead verification — own the system-level verification strategy for new product development, facilitating protocol and report generation across internal and external test labs.
• Own goals & planning — set and monitor department goals to achieve corporate and project objectives, and own project planning, budgeting, and scheduling.
• Partner cross-functionally — work closely with Quality Assurance, Supply Chain, Regulatory, and Clinical to keep programs moving.

• System Architecture & Requirements — own the end-to-end architecture and requirements strategy across electro-mechanical and software systems.
• Design Excellence & Compliance — ensure system-level designs meet regulatory standards and human factors requirements the first time.
• Hands-On Technical Leadership — stay close enough to the work to personally drive requirements translation and verification when a program needs it.
• Team Building & Development — grow a high-performing systems engineering organization built to scale with the company.
• Cross-Functional Partnership — work seamlessly with Quality, Supply Chain, Regulatory, and Clinical to bring products to market.

• Direct management of the Systems Engineering department, including performance reviews and professional development planning.
• Oversight of design contractors, co-ops, and interns as needed.

• BS in Engineering plus 10+ years of systems engineering experience for medical devices, including experience managing an engineering team.

• Advanced degree (MS/PhD) in Engineering.
• Direct knowledge of regulatory requirements and industry standards in the medical device industry.
• Strong leadership skills with experience leading teams through complex research projects from concept to completion.
• Deep knowledge of the state of the art for system-level requirements development and management, human factors, and verification and validation for medical devices.
• Proven ability to lead a team (internal and external) to deliver high-quality, complex electromechanical medical devices compliant with US and international requirements.
• Class II or III medical device experience.
• Hands-on experience designing, testing, and formally verifying electro-mechanical systems with remote monitoring capability.
• Clear, confident communicator, written and verbal.
• Comfortable exercising independent judgment and driving results autonomously.

• In office environment.

As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary.

TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. 

Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. 

Maximize your potential at TransMedics, Inc. 

www.TransMedics.com 

TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $220,600-$314,050, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.

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.