Senior Project Engineer, New Product Development

TransMedics Group • Andover, MA

109d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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

What This Job Offers

• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees