Senior Director, Systems Engineering

transmedics; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

TransMedics is seeking a Sr. Director of Systems Engineering to own the system-level architecture, requirements, and verification strategy across electro-mechanical and software domains for the Organ Care System (OCS).

This senior leadership role sits on the R&D leadership staff and drives multi-year architectural strategy while translating requirements into subsystem design when under pressure. The candidate will lead design teams, oversee verification activities, and collaborate with Quality,

Qualifications

• BS in Engineering and 10+ years of systems engineering experience for medical devices with team leadership.
• MS/PhD in Engineering preferred.
• Direct knowledge of regulatory requirements and industry standards in the medical device industry.

Responsibilities

• Set department strategy for Systems Engineering within R&D.
• Own system architecture and requirements for next-generation Organ Care Systems, ensuring regulatory compliance.
• Lead internal and external design teams for new products.
• Stay hands-on and translate requirements into design translations, verification, and validation.
• Lead system-level verification strategy for new product development and testing protocols.
• Own department goals, planning, budgeting, and scheduling.
• Partner cross-functionally with Quality Assurance, Supply Chain, Regulatory, and Clinical to move programs.

Skills

Leadership

System architecture

Regulatory compliance

V&V planning

Cross-functional collaboration

Hands-on technical leadership

Medical device experience

Education

BS in Engineering

MS/PhD in Engineering

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 p