Position OverviewDevelop and optimize the disposables systems and subsystems for TransMedics' Organ Care System (OCSTM) using advanced engineering techniques. Design products and solutions, and verify them through appropriate tools and testing, defining and executing the appropriate test protocols. Design subsystems being part of TransMedics' Organ Care System (OCSTM) taking care of all the aspects related to performances, design, design control, submission strategy and change control.Key ResponsibilitiesDevelop product configurations and variants to meet different organ-specific requirementsCollaborate with cross-functional teams to refine designs based on testing feedbackCreate design documentation including technical specifications, BOMs, and assembly instructionsSupport prototyping, testing, design verification & validation activities aimed to develop/improve the devicesTake part to the design for manufacturing (DFM) and design for assembly (DFA) initiativesManage DHF and Risk management file of the devicesMonitor the restrictions applied to the materials utilized on the disposables (e.g. ECHA...)RequirementsBachelor's or Master's degree in Mechanical Engineering or related field or ITS product development3+ years experience in mechanical design for medical devicesKnowledge of systems and subsystems used in medical devices environmentsDeep knowledge of ISO 13485 and other standards applied to medical devicesKnowledge of engineering materials and manufacturing processesUnderstanding of mechanical design principlesExperience with design control processes for regulated medical devicesExcellent attention to detail and spatial visualization skillsHighly motivated to enhance the products, the techniques and consequently the life of the patientsAbility to work in an international and fast moving environmentGood communication skills in EnglishGood knowledge of Microsoft Office suite;Willingness to relocate to Mirandola, Italy