Senior Director, Systems Engineering

TransMedics, Inc.•Andover, MA

3d•$220,600 - $314,050•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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.

Responsibilities

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