Senior Director, Systems Engineering

TransMedics, Inc.; Andover (MA); On-site; USD 221,000 - 314,000; Full time

Benefits offered by this job

Medical with HRA

Dental & Vision

Flexible Spending Account

Dependent Care Flexible Spending

Short Term Disability

Long Term Disability

401K Plan

Employee Stock Purchase Plan

Job summary

TransMedics, Inc. is seeking a Sr. Director of Systems Engineering to define and own the system-level architecture for the Organ Care System, uniting electrical, mechanical and software design to support organ perfusion.

This is a senior leadership role on the R&D staff, directly shaping the long-range technical strategy and multi-year architecture while translating requirements into concrete plans. You will lead cross-functional teams, drive verification strategy, manage budgets, and partner

Qualifications

• BS in Engineering with 10+ years of systems engineering experience in medical devices.
• Experience leading an engineering team and managing architectures.
• Direct knowledge of regulatory requirements for medical devices.

Responsibilities

• Define and own system architecture across electro-mechanical and software components.
• Lead requirements, design, testing, verification and validation.
• Set department strategy, goals, and budgets.
• Collaborate cross-functionally with Quality, Regulatory, and Clinical teams.
• Manage external design contractors and internal teams.

Skills

System architecture

Leadership

Requirements translation

Verification & validation

Cross-functional collaboration

Education

BS in Engineering

MS/PhD preferred

Job description

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.

Key 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.

Strategic Focus Areas

• 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.

Management Responsibilities

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

Minimum Qualifications

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

Preferred Qualifications

• 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.

Work Environment

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. Every Organ Wasted is a Life Not Saved.

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

Company Overview

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.

EEO Commitment

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.

Additional Information

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.