Senior Director, Systems Engineering

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.
• 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.