Senior Mechanical Design Engineer
Descrizione dell'offerta
Position Overview
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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
- 7+ 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 xdwybme 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 and fast moving environment
- Good communication skills in English
- Good knowledge of Microsoft Office suite;
- Willingness to relocate to Mirandola, Italy