Angela Lentini
Sr Systems Engineer Active Medical Device Peritoneal Dialysis & Pediatric Hemodialysis Systems @Mozarc Medical
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WORK HISTORY
Sr Systems Engineer Active Medical Device Peritoneal Dialysis & Pediatric Hemodialysis Systems @Mozarc Medical
Mirandola, IT
Senior Systems Engineer con responsabilità su sistemi complessi per dispositivi elettromedicali regolamentati- Guida sulla definizione e funzionamento dell’architettura del sistema di allarmi in conformità alla IEC 60•••18- Gestione delle attività di Risk Management secondo ISO 14971 (hazard analysis, FMEA, risk control)- Sviluppo e revisione di requisiti di sistema e sottosistema, garantendo tracciabilità lungo il V-Model- Redazione e revisione di Functional Specification e documentazione tecnica- Definizione e modellazione di diagrammi di stato (state machine)- Collaborazione con team internazionali per assicurare compliance normativa e allineamento tecnico
EDUCATION
Politecnico di Torino
Master's degree, Biomedical Engineering
University Magna Graecia of Catanzaro
Bachelor's degree, Informatics and Biomedical Engineering
Accademia Executive formazione Manageriale
Master in Project Management, Project Management
Ascheri Academy
The Business Plan: What it is, what it is used for, how it is built
Gruppo MIDI S.r.l
Master in Quality Management Systems for Medical Device companies
SKILLS
ABOUT ANGELA LENTINI
Lead Systems Engineer with 8+ years of experience in the development of active and non‑active medical devices within highly regulated environments.I lead system architecture, requirements engineering, and risk management activities, ensuring system robustness, full traceability, and compliance with international standards including ISO 14971, IEC 60601, and MDR 2017/745.I work closely with R&D, Quality, Regulatory, and international stakeholders, contributing to high‑impact technical decisions across the full product lifecycle. My approach combines strong engineering rigor, system‑level thinking, and a constant focus on patient safety and product reliability.
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