Position Overview Se sta pensando di inviare una candidatura, si ricordi di premere il pulsante apposito dopo aver letto l'intera descrizione. Develop and optimize the disposables systems and subsystems for TransMedics' Organ Care System (OCS™) 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 (OCS™) taking care of all the aspects related to performances, design, design control, submission strategy and change control.
Key Responsibilities
Develop product configurations and variants to meet different organ-specific requirements
Collaborate with cross-functional teams to refine designs based on testing feedback
Create design documentation including technical specifications, BOMs, and assembly instructions
Support prototyping, testing, design verification & validation activities aimed to develop/improve the devices
Take part to the design for manufacturing (DFM) and design for assembly (DFA) initiatives
Manage DHF and Risk management file of the devices
Monitor the restrictions applied to the materials utilized on the disposables (e.g. ECHA…) Requirements
Bachelor's or Master's degree in Mechanical Engineering or related field or ITS product development 3+ years experience in mechanical design for medical devices
Knowledge of systems and subsystems used in medical devices environments
Deep knowledge of ISO 13485 and other standards applied to medical devices
Knowledge of engineering materials and manufacturing processes xdwybme
Understanding of mechanical design principles
Experience with design control processes for regulated medical devices
Excellent attention to detail and spatial visualization skills
Highly motivated to enhance the products, the techniques and consequently the life of the patients
Ability to work in an international and fast moving environment
Good communication skills in English
Good knowledge of Microsoft Office suite;
Willingness to relocate to Mirandola, Italy