Senior Project Engineer, Sustaining Engineering

Job Description:

POSITION SUMMARY

Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships. The Senior Project Engineer 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 Engineer serves as a technical leader, mentor, and key contributor to new product development initiatives.

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

Occasionally lift and/or move objects: Typically ranging up to 25 or 50 pounds.

Standing for extended periods:

While observing work or interacting with on-site teams.

Sitting:

Particularly during desk work, meetings, and computer-related tasks. Up to 10% Domestic and/or international travel may be required.

MINIMUM QUALIFICATIONS

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related technical field. 5+ years of engineering or project management experience in the medical device industry.

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.). 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. 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. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary. 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 committed to equitable and transparent compensation. The expected base salary range for this role is $132,100.00- $164,850.00 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. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ's natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. - aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.