As Device Lead I drive large technical work programs with a cross-functional team. I provide technical project management of all aspects of the design process. I work with other members of the product development and extended technical teams to translate product requirements into product specifications. I indentify and evaluate external partners (consultants, laboratories, goods suppliers) in collaboration with relevant QA departments. I actively participate in multidisciplinary processes… Show more As Device Lead I drive large technical work programs with a cross-functional team. I provide technical project management of all aspects of the design process. I work with other members of the product development and extended technical teams to translate product requirements into product specifications. I indentify and evaluate external partners (consultants, laboratories, goods suppliers) in collaboration with relevant QA departments. I actively participate in multidisciplinary processes (design and process risk assessment) to identify and assess risks and to determine mitigations and controls related to the product design and manufacturing processes. I manage the design transfer of all specifications, design and development history documentation from R&D to GMD. I support design verification testing activities Show less

Responsible and accountable for leading the project team and drive projects from the feasibility phase to the post-launch, including the part of the product lifecycle. Collaborate with Marketing, QA/RA, Operations, Supply Chain, Finance etc. to ensure all aspects of the project requirements are considered, managed and delivered on time and budget. Perform budgeting analysis; create and maintain the Business Plan for projects. Planning and supervision of Verification & Validation tests for… Show more Responsible and accountable for leading the project team and drive projects from the feasibility phase to the post-launch, including the part of the product lifecycle. Collaborate with Marketing, QA/RA, Operations, Supply Chain, Finance etc. to ensure all aspects of the project requirements are considered, managed and delivered on time and budget. Perform budgeting analysis; create and maintain the Business Plan for projects. Planning and supervision of Verification & Validation tests for product development and changes. Support the Production process validation (IQ/OQ/PQ). Supervise the Design Transfer to manufacturing phase Show less

Drive research for innovative technical solutions of new products design and sustain existing products life-cycle. Ensure compliance to regulations and international standards related to medical devices during the whole design development process (ISO 13485, Medical Device Regulation). Contribute to the project management and influence strategic decisions.

Influence innovation and cooperate to the development of new products and technologies. Define requirements, lead the verification and validation on new product/technology. Perform root cause analysis of machine-material interaction issues and implement corrective actions. Ensure compliance with the specifications of package and closures according to standards and methods. Develop new procedures, tests and validation methods.

The six-month project, towards completion of Master Thesis, has been developed in collaboration with a team of cardiologist and engineers that work on the research of innovative treatments for cardiac diseases. The work was to evaluate the fluid-dynamic performances of a novel aortic valve by means of both computational fluid-dynamic simulations (CFD) and in-vitro hydrodynamics testing methods. A patient-specific 3D anatomy of the heart was also built with image processing technique to prove… Show more The six-month project, towards completion of Master Thesis, has been developed in collaboration with a team of cardiologist and engineers that work on the research of innovative treatments for cardiac diseases. The work was to evaluate the fluid-dynamic performances of a novel aortic valve by means of both computational fluid-dynamic simulations (CFD) and in-vitro hydrodynamics testing methods. A patient-specific 3D anatomy of the heart was also built with image processing technique to prove the effectiveness of the CFD model. Master Thesis title: “Experimental and computational assessment of a novel sutureless bioprosthetic aortic valve”.The work has been published in the “Cardiovascular Engineering and Technology” scientific journal. Show less