Job Description\n\nPOSITION SUMMARY\n\nWe are seeking an experienced engineer to develop and industrialize robust manufacturing processes for TransMedics’ innovative disposable medical device systems that support life-saving organ transplant technologies. This role partners closely with R&D;, Advanced Manufacturing, and key stakeholders to ensure seamless transition from concept and prototyping through scalable production, ensuring process reliability and product quality. This individual will play a critical role in advancing breakthrough technologies that improve patient outcomes worldwide through technical rigor, innovation, and operational excellence.\n\nResponsibilities\n\nThis position is responsible for, but not limited to, the following:\n\nResponsible for the development of manufacturing processes involved in New Product Development of disposable systems, sharing the vision with the VP of Disposables Development and the main stakeholders.\nEnsure Robust Design of TMDX Disposables devices creating Robust manufacturing processes, taking part to design, prototyping and testing activities and being responsible for an extremely accurate and detailed analysis based on an initial limited number of data obtained from the prototyping phase, finally moving to the transfer of design to Manufacturing.\nWork intensively with R&D; members (e.g. mechanical, prototyping and test engineers) and Advanced Manufacturing engineers, applying technical and engineering skills to ensure design for manufacturability.\nDefine technical specifications aimed to the realization of equipment for prototyping, testing and manufacturing, in cooperation with internal stakeholders and external suppliers. \nDefine test methods and protocols for the characterization of the technical features and the CTQ.\nTransform the prototyping phases into physical / technical parameters leading to the definition of manufacturing processes and production recipes.\nApply the expertise developed in devices manufacturing to investigate physical failures through reverse engineering, autopsies of devices, measurements and inspections using either destructive or nondestructive methods.\nPerform other TransMedics tasks and duties as assigned/required. \n\nManagement Responsibilities\n\nThis position will not have management responsibilities.\n\nPHYSICAL ATTRIBUTES\n\nNo Physical attributes \n\nMinimum Qualifications\n\nBroad technical experience in biomedical device environment, manufacturing processes and equipment of disposables, polymeric, testing and characterization methods, measurement systems;\n7+ years of experience in medical devices;\nDegree in mechanical / mechatronic / biomedical / physics engineering or equivalent;\nDeep knowledge of statistics;\nAbility to bring disruptive medical technologies from concept to commercialization\nKnowledge of statistics\nProven track record leading technical teams to successful product launches\nAbility to work in an international environment\nHighly motivated to enhance products, techniques and consequently the life of the patients\nExcellent communication skills in English; Italian language skills preferred\nGood knowledge of Microsoft Office suite;\nWillingness to relocate to Mirandola, Italy\n\nEvery Organ Wasted is a Life Not Saved.\n\nTransMedics, 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.\n\nDriven 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.\n\nMaximize your potential at TransMedics, Inc.\n\nwww.TransMedics.com\n\nTransMedics 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.