Manufacturing Engineer II

Job Description:

POSITION SUMMARY

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

RESPONSIBILITIES

This position is responsible for, but not limited to, the following:

• 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.

MANAGEMENT RESPONSIBILITIES

This position manages the following positions on a daily basis.

• This position will not have management responsibilities.

PHYSICAL ATTRIBUTES

• General Office Environment
• Ability to lift up to 25 pounds                                                                                             

MINIMUM QUALIFICATIONS                                                         

• 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.

PREFERRED QUALIFICATIONS

• 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.

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 $81, 250.00 – $101,350.00, 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.

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.