Company: Sixtema Srl - Ricerca e selezione del personale
Region: Mirandola , Emilia-Romagna
Position Overview
Develop and optimize the accessories and the perfusion tubing system of the disposables for Organ Care System (OCS). Design products and solutions being part of '' Organ Care System (OCS) taking care of all the aspects related to the components and the layout of the disposables lines including the design, the verification and the manufacturability within the System / Subsystems.
This specialized role focuses on ensuring optimal product design and manufacturability through engineering analysis.
Key Responsibilities
- Responsible for the development of the accessories and the perfusion tubing systems of Organ Care System (OCS) platform, securing the R&D project deliverables in terms of Quality, Cost and Time, sharing the overall vision with the VP of Disposables Development and the main stakeholders involved in the projects. This role focuses on innovating the key performances and the technologies for organ preservation during transplantation procedures.
- Identify the proper configuration of the accessories and the disposables lines optimizing the layout for each OCS system, finding the best components available on the market and cooperating with internal and external stakeholders for customized components/subassemblies to secure their implementation with a data driven approach.
- Work is close cooperation with the VP of Disposables Development, the end users (e.g. Clinical eng) and the engineering members of the Team, leveraging on his/her technical expertise to realize the disposables accessories, bringing innovation to the TMDX devices.
- Work in close cooperation with RA/QA and the engineering members to ensure the submission strategy.
- Coordinate the project tasks leveraging internal and external resources involved in the project.
- Constantly monitor the evolution of the project, identify technical risks and mitigations and secure the KPI leading to the success of the project, in cooperation with the Intelligence engineering and the main stakeholders.
Knowledge, skills and abilities required
- Broad technical experience in design of accessories for medical devices and manufacturing processes of disposables, polymeric, biomedical device environment, measurement systems;
- Extensive knowledge of components and subassemblies used in disposables lines
- At least 7 years of experience in medical devices;
- Degree in mechanical / mechatronic / biomedical engineering or high school diploma in technical field associated to extended experience in the same role;
- Excellent analytical and problem-solving skills
- Good communication skills in English; Italian language skills preferred
- Ability to work in an international environment
- Highly motivated to enhance the products, the techniques and consequently the life of the patients
- Good knowledge of Microsoft Office suite;
- Willingness to relocate to Mirandola, Italy