Manufacturing Engineer II

TransMedics, Inc.•Andover, MA

20h•Onsite

About The Position

The Manufacturing Engineer at TransMedics supports the production of perfusion set and Organ Care System (OCS) products. Working closely with cross‑functional teams in quality, planning and operations, 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 position offers hands‑on involvement in equipment maintenance, process development and validation of production processes. Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships.

Requirements

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

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.
Experience with Solidworks to create 3D models and drawings to support manufacturing assembly models, fixture design and development, and sustaining engineering activities.
Experience working directly with production staff to improve manufacturing processes.
Experience with plastic assembly, hardware assembly, electromechanical assembly and test processes.
Familiar with statistical evaluation software/tools.
Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus.
Exposure to root cause investigations and CAPAs.
Proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities.
Must possess a strong work ethic, effective oral and written communication skills and excellent interpersonal 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.
Assist in the introduction of new products and processes into production including selection, design, installation and maintenance of equipment, tooling, and fixtures.
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.