Consulente Freelance – R&D Medical Device
2 ore fa
TS Quality & Engineering cerca un Consulente Freelance – R&D Medical Device & Design Control
TS Quality & Engineering è alla ricerca di un
consulente freelance esperto in R&D Medical Device e Design Control
da coinvolgere in progetti innovativi per clienti operanti nel settore
Medical Devices
.
Attività principali
- Supporto alle attività di
Ricerca & Sviluppo
di dispositivi medici - Gestione e applicazione dei processi di
Design Control - Progettazione meccanica
- Redazione e revisione della documentazione tecnica (Design History File – DHF, Risk Management File, Verification & Validation, ecc.)
- Collaborazione con team R&D, Qualità, Regulatory e Produzione
- Supporto a audit e ispezioni regolatorie
- Applicazione normative e standard di riferimento (MDR, ISO 13485, ISO 14971, IEC 62304, IEC 62366)
Requisiti
- Esperienza comprovata in ambito
Medical Device R&D - Conoscenza progettazione meccanica ed utilizzo di almeno un sistema CAD (Creo o Solidworks)
- Solida conoscenza dei processi di
Design Control - Conoscenza delle normative MDR e standard ISO applicabili
- Autonomia operativa e approccio consulenziale
- Ottime capacità di documentazione tecnica e comunicazione
- Partita IVA
Nice to have
- Esperienza su dispositivi medicali software, hardware o combinati
- Coinvolgimento in progetti di sviluppo end-to-end (concept → industrializzazione)
- Conoscenza progettazione elettronica e/o Software
- Esperienza con enti notificati
- Disponibilità a operare su progetti on-site / hybrid / remote
Cosa offriamo
- Collaborazione freelance su progetti strutturati e ad alto contenuto tecnico
- Contesto dinamico e altamente specializzato nel mondo Medical Device
- Flessibilità operativa
- Possibilità di collaborazione continuativa
Interessato/a?
Scrivici in privato o inviaci il tuo profilo con una breve descrizione dell'esperienza in ambito R&D Medical Device e Design Control.
MedicalDevice #DesignControl #R&D #ISO13485 #MDR #ConsulenteFreelance #TSQuality #QualityEngineering-
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