Zouhair ENNARA

En résumé

Entreprises

• Novartis - Human Factors Engineer

  RUEIL MALMAISON 2016 - maintenant Scope:
  Usability management of medical devices regarding European standards (IEC: 62366-1:2015) and US standards (510k)
  Products are pre-filled syringes and others devices for intravitreal injection. Intended users are ophthalmologists
  
  Activities:
  - Management Human Factors Engineering Process for Medical Devices
  - Writing of Application Specifications (Users requirements)
  - Material vigilance and recording of known use problems on FDA databases (MAUDE)
  - Writing of Task Analysis/Use Scenarios
  - Management of ergonomic tests on forces applied to a medical device on usability studies
  - Formative & Summative Tests Plan/Procedure/Report
  - Writing of Instructions for Use (IFU)
  - Collaborate with partners (Human Factors Specialists/vendors)
  
  Standards IEC 62366:2007 and IEC 62366-1:2015
  Guidance ANSI/AAMI HE75:2009 - Human factors engineering— Design of medical devices
  Standard ISO 14971:2007 - Risk Management for Medical Devices

• Fresenius - Consultant - Usability Pilot

  Fresnes 2014 - maintenant Context:
  The launch of a system of major products is planned for 2015
  
  Scope:
  Usability management of medical devices regarding European standards (IEC: 62366:2007) and US standards (510k)
  Products are infusion pumps which delivered drugs by intravenous route. Intended users are nurses and physicians (Oncology, ICU…)
  
  Activities:
  Before usability studies:
  Writing of a master plan (Planning of formative and summative studies; establishment of usability requirements; definition of acceptance criteria)
  Writing of usability protocols
  Delivery of documents and material needed
  Performing usability studies with intended users in a simulated environment
  
  Usability studies outputs:
  Organisation of Workshops with departments involved (Risk Management, Project teams; QA, Marketing)
  Writing of design reviews; formative and Summative reports; Usability Engineering Files
  Writing of templates for row data analysis; tests protocols and reports

• The Linde Group - Biomedical Engineer - Specialist Field

  Saint-Priest 2012 - 2014 Context:
  In a very competitive sector, Linde Healthcare launched a medical device
  Primary operating functions: Administration and monitoring of gases administered through the respiratory route, for patients suffering of respiratory disease.
  The device is used in Intensive Care Units by nurses, physicians (Primary operating functions) and biomedical engineers (others functions related to safety)
  Activities:
  Training of intended users to the use of medical devices in hospitals
  Regulatory Affairs - Set up of complains related to the use of a medical device:
  Root cause analysis and data’s recording on a specific complains database
  Writing of accompanying documents (Summary of use; Quick Start Guide)
  Validation test with biomedical engineers in real use environment and writing of a test report
  Reviewing the translation of the IFU (Instructions for Use) of prototype devices from English into French as a French native speaker reviewer and as a person skilled in the art

• BIO-RAD - Application Engineer - Specialist Field

  Marnes La Coquette 2008 - 2011 Context:
  The company is specialized on diagnostic in vitro medical devices.
  Product/ Medical Indication/ Way of administration/ Intended Users and Environment:
  The products are In Vitro Diagnostic medical devices for diabetes (HPLC). The analysis is performed with blood samples (no direct contact with patients) by laboratories technicians and biologists.
  
  Realizations/ Activities:
  • Installation, follow up and maintenance of devices and software’s:
  o Medical devices
  o Quality Control Software’s MSSQL databases
  • Training on the field to the use of In vitro diagnostic devices
  • Validation of a medical device already on the market according the ISO/15189 standard
  • Follow up of customer testing in real use environment

Formations

• GEMS

  Boulogne Billancourt 2014 - 2014 Titre de Visiteur Médical
  
  Connaissance de la Charte de la visite médicale, et des règles régissant la publicité des dispositifs médicaux (Loi Bertrand et loi DMOS) dans le but de renforcer le rôle de la visite médicale dans le bon usage du médicament et la qualité de l'information sur le médicament

• Université Lyon 1 Claude Bernard M2P Phytoressources

  Villeurbanne 2006 - 2008 master
  
  Chimie et Biologie Végétale

• Université Besançon Franche Comte (Besancon)

  Besancon 2005 - 2006 Licence Professionnelle
  
  Traitement des Eaux et Gestion de l'Environnement

• Université Besançon Franche Comte

  Besancon 2002 - 2005 DUT

Réseau

• Andry ANDRIAMADY

• Emilie PEBOU POLAE

• Frédérique AMPILHAC

• Hamid ARBOUCHE

• Recruteur CVO-EUROPE

• Sophie BERTRAND-TROUILHET

• Sophie DAVID

• Stéphane ANDRÉ

• Virginie RACANO

• Xavier CONCA