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Immanuel Bader

Angestellt, Senior berater für QM-Systeme, Usability & Regulatory Affairs, Johner-Institut GmbH
Frankfurt am Main, Germany

Skills

Application lifecycle management
Project management
Product management
Mobile Platform’s
ISO 13485
ISO 14971
IEC 62304
IEC 62366
Requirements Engineering
App UX Design
MDD
MDR
FDA
Medical Devices
Regulatory Affairs
Human Factors and Usability engineering
Consulting

Timeline

Professional experience for Immanuel Bader

  • Current 6 years and 2 months, since Feb 2019

    Geschäftsführer

    Johner Institute North America Inc.

  • Current 8 years and 7 months, since Sep 2016

    Senior berater für QM-Systeme, Usability & Regulatory Affairs

    Johner-Institut GmbH

    Consulting in: * Technical Documentation and Software development according to ISO 62304 also agile development practices in pharma and medical device companies * Risk management according to ISO 14971 * Quality Management Systems according to ISO 13485:2016 * Audits of Quality management Systems * Human Factors and Usability engineering according to ISO 62366 and FDA HF-Guidance including formative and summative usability evaluations

  • 4 years and 4 months, May 2012 - Aug 2016

    Software Manager

    Sanofi-Aventis Deutschland GmbH

    Application Lifecycle Management Software Project Management Product Management Requirements Engineering

  • 2 years and 1 month, Apr 2010 - Apr 2012

    Project Manager

    VEPRO AG

    Project Management Project Documentation Resource Planing Product Management (PACS and RIS) Interface Coordination (HL7)

  • 1 year, Aug 2008 - Jul 2009

    IT Technician / Administrator

    Ozzyconnect (Brisbane, Australia)

    Network administration Windows Server 2003 administration VPN administration Develop projekt web pages and administrate them Content management for websites

  • 1 year and 1 month, Aug 2006 - Aug 2007

    Network Administrator and Web Developer

    AMAN Media GmbH

    Administration of webservers (Apache, MySQL, PostgreSQL, Rsync for backups, HA) running operating systems like: Debian, Suse and RedHat Performing regular failover tests Monitoring of the server infrastructure Writing bash scripts Writing some code in PHP and JavaScript

Educational background for Immanuel Bader

  • 1 year and 11 months, Sep 2014 - Jul 2016

    Information Technologies in Healthcare (Medizinische Informatik)

    Donau-Universität Krems / Johner-Institut

    Management Gesundheitswesen Recht Informationssysteme im Gesundheitswesen Projekt- und Prozessmanagement Betriebswirtschaftslehre

  • 2 years and 1 month, Sep 2004 - Sep 2006

    Informatik

    Hermann Schmid Akademie – Rudolf Diesel Berufsfachschule

    • Microcontroller programming • Object oriented programming • Electrical engineering • Network technology • Operating systems: Windows Server 2003 and Linux

  • 1 year and 1 month, Apr 2002 - Apr 2003

    Multimedia

    SAE Collage

    • Design (Photoshop) • Animation (Cinema 4D) • Web development (HTML, JavaScript)

  • 2 years and 1 month, Sep 2000 - Sep 2002

    IT - technician

    Elektrotechnik Harald Käs

    • Network technology • Cabling (LWL and copper) • Active network components

Languages

  • German

    First language

  • English

    Fluent

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