Project Engineer, New Product Development

Job Description:

TransMedics was founded to address the unmet need for more and better organs for transplantation and has developed the Organ Care System (OCS) technologies to preserve organ quality, assess organ viability prior to transplant, and potentially increase the utilization of donor organs for the treatment of end-stage heart, lung, and liver failure. TransMedics' National OCS Procurement (NOP) program was developed to maximize the utilization of donor organs in the US.

The Project Engineer - New Product Development will be a key contributor in the design and development of next-generation organ transport and perfusion systems, advancing the mission of extending transplant viability and patient outcomes. This role supports the end-to-end development of capital systems and disposable components, working across mechanical, electrical, and software domains. The engineer will ensure products are safe, effective, and compliant with global regulatory standards.

RESPONSIBILITIES:

This position is responsible for, but not limited to, the following:

• Lead or support development of complex organ transport systems, including portable perfusion devices integrating fluidics, thermal control, sensors, and embedded electronics.
• Translate clinical, user, and regulatory requirements into system-level and component-level design inputs.
• Design and iterate subsystems such as organ chambers, blood/gas/fluid loops, temperature control elements, and user interface features.
• Execute and document design verification, validation, and risk management activities per ISO 13485 and FDA QSR (21 CFR Part 820).
• Develop prototypes for benchtop and simulated-use evaluations.
• Collaborate with cross-functional teams (R&D, Quality, Regulatory, Clinical, Operations, and Commercial) to drive design from concept to commercialization
• Interface with external suppliers and contract development partners to source components, manage tolerances, and ensure DFM/DFA.
• Contribute to design history files (DHF), technical documentation, and submission packages.
• Apply systems engineering principles to ensure robust integration across hardware, disposables, and software components.
• Support design transfer and pilot production activities, troubleshooting issues related to manufacturability and product performance.
• Develop and manage comprehensive program plans, including scope, schedules, budgets, and resource allocation, to deliver new product development projects on time and within budget.
• Manage vendor relationships for third-party components, including software platforms, contract manufacturers, and testing partners.
• Serve as the primary point of contact for program communications, both internally and externally, including with senior leadership and strategic partners.
• Track and report on key program metrics, escalate issues appropriately, and drive resolutions.
• Identify and implement process improvements to enhance program delivery and team efficiency.
• Lead continuous improvement initiatives to optimize program management processes.
• All other duties as assigned

QUALIFICATIONS:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related technical field.
• 3-7 years of experience in medical device product development or regulated industry.
• Strong understanding of product development lifecycle in a regulated environment.
• Proficiency with CAD tools (e.g., SolidWorks), project management tools, and basic statistical analysis.
• Working knowledge of design controls, risk management, and verification/validation processes.
• Experience with capital equipment, disposables, or software-enabled devices is a plus.
• Excellent communication, problem-solving, and interpersonal skills.
• Self-starter with the ability to manage multiple priorities and meet deadlines in a fast-paced environment.

PREFERRED SKILLS:

• Experience with Class II or Class III medical devices.
• Experience with electrical or software integration in medical systems.
• Familiarity with rapid prototyping, tolerance analysis, and DFM/DFA.
• Exposure to usability engineering and human factors.
• Experience in working with global development teams or suppliers.

Every Organ Wasted is a Life Not Saved.

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 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.