Manufacturing Engineer I

TransMedics, Inc.•Andover, MA

1d•$65,400 - $81,800

About The Position

The Manufacturing Engineer at TransMedics contributes to the introduction and scale‑up of perfusion set and Organ Care System (OCS) products. Working closely with cross‑functional teams in product development, quality, and manufacturing engineering, this role defines, implements, and validates robust manufacturing processes. The engineer develops and optimizes assembly and test methods to ensure Critical‑to‑Quality (CTQ) standards, supports risk assessment (PFMEA) and DFM/DFA efforts, and drives documentation such as work instructions and engineering change orders. This entry‑level position offers hands-on involvement in process development, capacity planning, and line readiness from prototype through production transfer.

Requirements

BS in Mechanical, Electrical, or Biomedical Engineering or other engineering discipline is required.
0-2 years of experience.
FDA/ISO regulated medical device/medical equipment manufacturing environment preferred.

Nice To Haves

Exposure to Process Development and/or Manufacturing Engineering, including the development and execution of Process Validation plans to support new and existing process and test equipment a plus.
Experience with Solidworks, and/or Pro Engineer to create 3D models and drawings to support manufacturing assembly models, fixture design and development, and sustaining engineering activities.
Familiar with statistical evaluation software/tools, Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus.
Detail oriented with strong organizational skills.
Able to work collaboratively in a cross-functional team environment.
Excellent verbal and written communication skills.

Responsibilities

Manufacturing Engineering activities associated with the production of TransMedics Organ Care System.
Work hands on with production staff to develop and maintain manufacturing processes.
Provide support related to existing and new manufacturing processes and work directly with production staff to improve, maintain, and provide support to such processes.
Develop and learn how to introducte new products and processes into production including selection, design, installation and maintenance of Equipment, Tooling, and fixtures used in Production.
Support continuous improvement project initiatives focused on improving product quality and reducing cost.
Creation of documentation including: Manufacturing Instructions, Inspection procedures, Test Protocols, Assembly drawings and Component Drawings.
Support Engineering team and Production team efforts to identify opportunities to streamline production through process improvements, test improvements, and product design changes.
Work with cross functional teams to assist in solving technical and quality related issues including participation in MRB, customer complaint investigations, CAPA related activities, design activities, and regulatory submissions.
Serve as strong team player, supporting and assisting supervisor and colleagues when necessary and comply with all work safety rules and regulations.
Perform other TransMedics tasks and duties as required.