TransMedics
Job Description:
Department of Manufacturing Engineering focuses on manufacturing of the Organ Care System at our headquarters in Andover, Massachusetts. The team works on developing, maintaining, and improving manufacturing processes to support our initiative to deliver the highest quality technology to save patients' lives.
POSITION SUMMARY RESPONSIBILITIES
This position is responsible for, but not limited to, the following:
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.
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.
Department of Manufacturing Engineering focuses on manufacturing of the Organ Care System at our headquarters in Andover, Massachusetts. The team works on developing, maintaining, and improving manufacturing processes to support our initiative to deliver the highest quality technology to save patients' lives.
POSITION SUMMARY RESPONSIBILITIES
This position is responsible for, but not limited to, the following:
- Manufacturing Engineering activities associated with the production of TransMedics Organ Care System.
- Provide technical expertise and support related to existing and new manufacturing processes. Work directly with production staff to improve, maintain, and provide support to such processes.
- Work hands on to develop manufacturing processes, participate in validation activities and analyze existing production processes.
- Complete continuous improvement project initiatives focused on improving product quality and reducing cost.
- Creation of documentation including: Manufacturing instructions, inspection procedures, test protocols, assembly drawings, equipment control documentation, and component drawings.
- Lead activities with the Engineering and Operations teams to identify opportunities to streamline production through process improvements, test improvements, and product design changes.
- Work with cross functional teams to identify and resolve 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 complying with all work safety rules and regulations.
- Provide mentorship and training to Jr level engineers and interns.
- Perform other TransMedics tasks and duties as assigned/required.Perform.
- BS in Engineering plus 8+ years of experience working as a Manufacturing Engineer or equivalent education and years of experience.
- Must have manufacturing engineering experience in a regulated environment preferably in an FDA/ISO Medical Device/ Medical Equipment Industry.
- Must have prior Manufacturing Engineering and/or Process Development experience including the development and execution of process validations to support new and existing process and test equipment.
- Must have prior experience leading the design, development, and validation of production fixtures and tooling.
- Must have prior work experience leading the development of plastic assembly, hardware assembly, electromechanical assembly and test processes.
- Previous experience working directly with production staff to improve manufacturing processes.
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.
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.