Senior Project Engineer, Sustaining Engineering

TransMedics, Inc.•Andover, MA

5d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.