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Mirandola, Emilia-Romagna, Italia
Onsite
Job Description:
POSITION SUMMARY
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
RESPONSIBILITIES
This position is responsible for, but not limited to, the following:
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 and validation activities aimed to develop/improve the devices
Take part to the design for manufacturing (DFM) and design for assembly (DFA) initiatives
Participate in design reviews and risk management activities
Manage DHF of the devices
Monitor the restrictions applied to the materials utilized on the disposables
Perform other TransMedics tasks and duties as assigned/required.
MANAGEMENT RESPONSIBILITIES
This position will not have management responsibilities.
PHYSICAL ATTRIBUTES
Standard Office Engineering Environment
MINIMUM QUALIFICATIONS
Bachelor's or Master's degree in Mechanical Engineering or related field or ITS product development
7+ years experience in mechanical design for medical devices
Knowledge of subsystems used in medical devices
Good knowledge of ISO 13485
Knowledge of engineering materials and manufacturing processes
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 environment
Good communication skills in English; Italian language skills preferred
Good knowledge of Microsoft Office suite;
Willingness to relocate to Mirandola, Italy
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.