Francesco Rinaldi
Product Quality Engineer
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Info
Bioengineering graduate with hands-on experience in quality laboratory activities within a regulated environment, focused on product validation for Class I medical devices in compliance with MDR and ISO 13485 / ISO 14971 standards. I am a curious and dynamic professional, strongly motivated to grow within the medical device sector, with particular interest in quality control, process engineering, clinical environments, and technical support or consultancy activities.
Esperienza
Product Quality Engineer at EssilorLuxottica (2024-03 – 2026-03)
- Identify and prevent quality issue starting from the prototyping to the final product industrialization.
- Product performance evaluation through mechanical, chemical, physical and optical analysis.
- Performed material analysis with advanced instruments (IR, SEM, XRF, LIBS, optical microscopy, microscratch).
- Product transport validation according to ASTM standards.
- Drafted and improving methods and test protocols in accordance with quality system requirements (ISO 13485 - ISO 14971) to reproduce market return issues or to validate new materials/processes.
- Performed root cause analysis (e.g., 5 Why, Ishikawa) and supported CAPA processes for nonconformities, ensuring effective resolution and prevention of recurrence
- Prepared technical reports and presentations for management (Excel, PowerPoint).
- Maintained laboratory data and test records within PLM systems, ensuring data integrity and traceability.
- Coordinated installation (IQ/OQ/PQ) of new analytical equipment (Total Fluorine) and liaised with suppliers.
- Operated Essilor instruments for lens cutting and testing (tracers, cutting machines, phoropters, autorefractometers).
- Supported medical logistics by transporting clinical materials and samples.
Logistic operator at Centro di Medicina (2022-07 – 2022-10)
- Supported medical logistics by transporting clinical materials and samples.
Formazione
MSc in Bioengineering – University of Padua (2021 – 2023)
BSc in Biomedical Engineering – University of Padua (2017 – 2021)
High School Diploma in Chemistry – Technical Institute E. Fermi (Treviso) (2012 – 2017)
