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
- 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
- Bachelors or Masters 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
Equal Opportunity Employer
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.
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