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 with rapid prototyping, tolerance analysis, and DFM/DFA.
• Familiarity with project management tools (e.g., MS Project, Smartsheet, JIRA, etc.).

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.

TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $132,150-$164,850, which represents the company's current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.

Employee Benefit
Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA

Dental

Vision

Healthcare Flexible Spending Account

Dependent Care Flexible Spending Account

Short Term Disability

Long Term Disability

401K Plan

Pet insurance

Employee Stock Purchase Plan

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.