Consulente Freelance – R&D Medical Device

2 ore fa


Asti, Piemonte, Italia TS Quality & Engineering A tempo pieno


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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