Tommaso Sironi

Chief Technology Officer at NIB biotec srl (2023-11 – Present)

NIB biotec is a startup developing IVD for the screening of the prostate cancer.

• Structure the R&D department.
• Plan and manage the development of the products from the concept to the market.
• Design and implement the manufacturing line.
• Implement and maintain the QMS in compliance with the ISO 13485 and the IVDR.
• Plan and manage the certification activities.
• Plan and manage the regulatory activities to access EU, USA, UK markets.

R&D Medical Director at Tenowo Italia srl (2022-09 – 2023-11)

Tenowo Italia, part of Tenowo GmbH, is the medical Device BU.

• The initiation and development of the R&D department.
• The creation of a 5-years projects pipeline.
• The creation of a network with European universities.
• The support to the other departments to structure the company for class II and III medical devices manufacturing.

R&D engineer, team leader at CoreMedic GmbH (2019-04 – 2022-08)

CoreMedic is a start-up focused on the development of a transcatheter device for the mitral valve repair. As R&D Engineer chief of design of the ChordArt C delivery system, I collaborated within the R&D team to the development, verification and validation of the ChordArt Implant, the ChordArt C delivery system, the implant procedure and the manufacturing processes.

• Design of the ChordArt C delivery system from the concept to the clinical validation.
• Definition and development of manufacturing processes (working instruction, tooling, inspection).
• Providing suppliers support for development and validation of external processes.
• Responsible for in-vitro and in-vivo testing.
• Managing external resources for testing support, both companies and universities research teams.
• Defines timeline and ensures project plan update.
• Design document maintenance (DHF, DMR, input-output matrix etc.)
• Panning and coordinating the manufacturing and prototyping.

Junior R&D engineer at InnovHeart srl (2017-06 – 2019-04)

InnovHeart is a start-up developing a novel Trans-Catheter Mitral Valve Prosthesis to solve mitral insufficiency. As R&D engineer my duties involved applying best practices to achieve the design and development of innovative products in terms of durability, usability and functionality; design, development and testing of the valve prosthesis; plan, writing protocol and report of preclinical test; support the maintenance of design documentation requirements according to internal Design Control Policy; V&V test in compliance with international standard.

Project engineer at Tecninox srl (2016-06 – 2017-06)

Manufacturer of systems for contamination and sterility control for pharma and biomedical industry. As project engineer, I was involved in the preparation of project technical documentation and the project management and coordination.

Student Researcher at Helmholtz Institute of RWTH Aachen University & Hospital (2014-05 – 2014-10)

As part of the master's thesis, project for the development of a structural numerical model experimentally validated for the durability analysis of Nitinol Transcatheter Aortic Valve (TAVI) within the cooperation with LaBS (Laboratory of Biological structure mechanics - Politecnico di Milano). I handled the experimental static and fatigue characterization of shape memory alloys, the development of a FE structural model of a TAV stent, the device FE simulation of fatigue test, the experimental durability test on the valve prototype.

Master degree in Biomedical Engineering - Biomechanics and Biomaterials – Politecnico di Milano (2012 – 2016)

Bachelor degree in Biomedical Engineering – Politecnico di Milano (2008 – 2012)

High school in Mathematics, Physics and Computer Science – B. Russell (2003 – 2008)