About me
Biomedical engineer
Quality and regulatory affairs · Oracle NetSuite · Electronic design
I am a biomedical engineer and have worked in the medical device sector since 2011. My work covers quality and regulatory affairs, the digitalisation of business processes and electronic design.
Alongside hands-on technical work, I coordinate multidisciplinary teams, set priorities and objectives, and follow activities through to reviewing the results. This experience enables me to connect product requirements with manufacturing, quality and information systems.
My work
Quality and regulatory affairs
I developed management systems and led the process that enabled the company to achieve ISO 9001, EN 9100 and ISO 13485 certification. I now oversee their maintenance, audits, non-conformities and corrective actions, liaising with internationally recognised certification bodies.
My regulatory work covers testing, manuals, technical files and medical device registrations. I manage documentation and verification activities, with experience in liaising with laboratories and relevant bodies and in international registration procedures.
Oracle NetSuite and digitalisation
I managed the implementation of Oracle NetSuite within the company and oversee its administration and ongoing development. I translate operational needs into configurations, customisations and integrations, maintaining existing solutions and developing new ones.
My experience includes systems for configuring products, calculating prices and preparing quotations (CPQ: Configure, Price, Quote), development with SuiteScript and Suitelets, and integrations between the ERP and external systems.
I coordinate a team of engineers working on business process improvements and the management and organisation of manufacturing bills of materials.
Electronic design
I design circuit schematics and printed circuit boards (PCBs), with particular experience in mobility aid applications.
I coordinate a team of engineers, external consultants, operators and students working on their theses, with responsibility for setting work priorities and reviewing results.
Professional collaboration
I provide consultancy in quality, medical device regulatory affairs, Oracle NetSuite and electronic design. For each assignment, I agree on objectives, activities and timelines, identifying where I can make the most useful contribution to the project.
Explore my expertise and completed projects
Education and qualifications
- Master’s degree in Biomedical Engineering — University of Naples Federico II, 2014.
- Bachelor’s degree in Biomedical Engineering — University of Naples Federico II, 2011.
- Order of Engineers of Naples — Section A, sector B, registration no. 20725; Section B, sector C, registration no. B653.
- Register of Court-Appointed Technical Experts, Naples North Court — registration no. 1702.
- CSWP — Certified SOLIDWORKS Professional, 2017.
Languages
- Italian: native speaker.
- English: used professionally; FCE B2 certification.
- French: DELF B2 certification; academic use.
- German: basic knowledge.
Publications
- Management sanitario: il complesso gestionale del rischio associato ai dispositivi medici — FS Editore, 2019.
- Il rischio informatico in sanità tra management ed evoluzione tecnologica — FS Editore, 2019.
Get in touch to discuss a project or professional collaboration
