Senior Project Manager, 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.

POSITION SUMMARY

The Senior Project Manager will lead the design, development, and implementation of complex medical devices, including capital equipment, disposables, and software-enabled systems for use in organ transportation and preservation. This role will work cross-functionally to ensure product performance, safety, and compliance with regulatory requirements, from concept through commercialization. The Senior Project Manager serves as a technical leader, mentor, and key contributor to new product development initiatives. Must have an engineering background.

RESPONSIBILITIES

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

• Lead end-to-end project execution for complex medical device systems that integrate capital equipment, disposables, and embedded software components.
• Develop and manage comprehensive program plans, including scope, schedules, budgets, and resource allocation, to deliver new product development projects on time and within budget.
• Oversee design control activities, ensuring robust documentation, traceability, and regulatory readiness.
• Contribute to design history files (DHF), technical documentation, and submission packages.
• Facilitate phase gate reviews and ensure documentation meets quality and regulatory standards.
• Track and report on key program metrics, escalate issues appropriately, and drive resolutions.
• Collaborate with cross-functional teams (R&D, Quality, Regulatory, Clinical, Operations, and Commercial) to drive project execturion.
• Serve as the primary point of contact for project communications, both internally and externally, including with senior leadership and strategic partners.
• Provide engineering expertise to support feasibility, prototyping, and manufacturing scale-up.
• Develop and review detailed design documentation, drawings, and specifications.
• Participate in design reviews, hazard analyses, and failure mode effects analyses (FMEA).
• Support Design for Manufacturability (DFM) and Design for Assembly (DFA) efforts.
• Support design transfer and pilot production activities, troubleshooting issues related to product performance.
• Identify and implement process improvements to enhance project delivery, team efficiency, and product quality.
• Perform other TransMedics tasks and duties as assigned/required.                                     

MANAGEMENT RESPONSIBILITIES

This position manages the following positions on a daily basis.

• This position will not have management responsibilities.

PHYSICAL ATTRIBUTES

• General Office Environment, may sit for extended periods of time.
• Up to 10% Domestic Travel
• Up to 5% International Travel
• Ability to lift up to 25lbs.                                                                                                    

MINIMUM QUALIFICATIONS                                                         

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical field.
• 7+ years of engineering and/or project management experience in the medical device industry.
• Strong understanding of product development lifecycle in a regulated environment.
• Experience with the design and development of complex medical device projects.
• Excellent communication, problem-solving, and interpersonal skills.

PREFERRED QUALIFICATIONS

• PMP or similar certification.
• Experience with Class II or Class III medical devices.
• Experience in CAD (SolidWorks or equivalent), simulation tools, and PLM systems.
• Experience with capital equipment, disposables, or software-enabled devices.
• Familiarity w