SaMD - Software as a medical device C++ 13485 Quality Management, 14971 Risk Management, 62304 Life Cycle, 62366 Usability and MDR
Aktualisiert am 02.02.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.04.2024
Verfügbar zu: 100%
davon vor Ort: 100%
C++
CE-Certification of SaMD
Computer assisted radiology and surgery
Node.JS
Javascript
3D
english
german

Einsatzorte

Einsatzorte

Düsseldorf (+50km) Hamburg (+50km) Zürich (+50km)
Deutschland, Schweiz
möglich

Projekte

Projekte

2019 - 2019: Custom Made Applications

Role: Capgemini

Customer: Bayer (Leverkusen)

Task:

  • Custom Made Applications @ Bayer / Capgemini India
  • Interface and team coordination
  • Validation Manager for computerized systems (GxP and SOP)

2009 ? 2018: Software development according

Role: Senior Software Developer

Customer: Dr. Sennewald Medizintechnik GmbH

Task:

Treatment planning software for regional deep hyperthermia / Online thermometry using magnetic resonance imaging to guide regional deep hyperthermia treatment

Environment and technologies:

  • Software development according to the Medical Device Directive and DIN EN-ISO 62304 (Medical device software ? Software life cycle processes), DIN EN-ISO 13485 (Medical devices -- Quality management systems -- Requirements for regulatory purposes), DIN EN-ISO 14971 (Medical devices -- Application of risk management to medical devices), DIN EN ISO 62366 (Medical devices -- Application of usability engineering to medical devices).
  • Full application life-cycle.
  • Development of fully integrated project data management system to satisfy CE relevant documentation requirements.
  • MS VC++ and OpenGL
  • DCMTK (Dicom Toolkit) VTK (Visualization Toolkit)
  • DigitalMars D Javascript

2005 - 2009: Requirements Engineering

Role: Senior Developer

Customer: QualityPark Berlin (System integration and tool development)

Task:

Requirements Engineering with Serena RM for UBS / Tool development and realization / Onsite support/development for UBS in Hong Kong and Zurich / System integration for Associated Press in Cranbury, New Jersey / System integration for Nokia Siemens Networks in Helsinki Finland

Environment and technologies:
Serena RM, Serena Business Mashups (Teamtrack), MS VC++, Eclipse, IBM Rational Software Modeller (Plugin development), Oracle, MSSQL, Java, Mercury QualityCenter, ALF


2004 - 2005: Auction data acquisition

Role: Software development (Freelancer)

Customer: eBay-Client and Server for Powerseller

Task:

C# based eBay Client for Auction data acquisition / Java/Tomcat based Server for Auction transmission to eBay (eBay API)

Environment and technologies:
.NET, Apache, C#, C++, Eclipse, GUI, HTML, HTTP, InstallShield, J2SE, JDK, JSP, Java, JavaBeans, Junit, MS-Access, MS-SQL-Server, MS-Visual Studio, POP3, SMTP, SQL, SSL, Struts, Windows 2000, Windows 2003, Windows NT, Windows XP


2004 - 2004: mySQL Database

Role: Software development (Freelancer)

Customer: Geo Information System for operation planning

Task:

  • mySQL Database / XSLFO PDF Creation (Invoice printing / Operation overview)
  • Berlin map for Operation planning

Environment and technologies:
AWT, Eclipse, GUI, J2SE, JDK, Java, ODBC, OO-Analyse, OODesign, OO-Programming


2003 ? 2004: RFB (VNC)-based application server

Role: Software development (Freelancer)

Customer: Taskit GmbH Berlin (Embedded systems) / Application Server for embedded systems (PDA + LCD thin client)

Task:

RFB (VNC)-based application server for PDA?s and thin client terminals.

Environment and technologies:
Borland C++ and Win32


2000 ? 2003: Catalog System

Role: Software development (Fulltime) 

Customer: jCatalog Dortmund

Task:

  • Catalog System (Tomcat/JSP/Tag libraries/GUI)
  • XSLFO-Editor (XSLT-Stylesheets, PDF On-the-fly from SAP)
  • Workflow Engine (GUI)

Environment and technologies:
Borland JBuilder, Tomcat, XSLFO, FOP


1999 - 2000: Software development

Role: Software development (Fulltime)

Customer: Fuzzy Logic Systems Dortmund / Expert system for credit decision CCBank

Task:

Environment and technologies:
Borland C++ Builder


1998 - 1999: Software development

Role: Software development (Freelancer)

Customer: Mesacon / Transputer Interface RS422 for industrial laser scanner devices

Task:

Environment and technologies:
x86 Assembler Interface Programming RS422


1997 - 1998: Software development

Role: Software development (Freelancer)

Customer: Architecture Mappingsystem for route planning

Task:

Environment and technologies:
IBM Visual Age for C++


1996 - 1997: Software development

Role: Software development (Freelancer)

Customer: Graphitti Software Cologne / Excel clone Spreadsheet application

Task:

Environment and technologies:
VC++ OCX development


1994 ? 1996: Software development

Role: Software development (Freelancer) 

Customer: IP Communication Bochum / Web development and Interactive Catalog

Task:

Environment and technologies:
Java and Borland Delphi

Aus- und Weiterbildung

Aus- und Weiterbildung

1991

Abitur Alexander Hegius Gymnasium Ahaus (Highschool)


1991-1994

Pre-degree Computer Science Technical University Berlin


2003-2007

Degree Computer Science Technical University Berlin

Study of computer science T.U. Berlin

Main topics: Computer Graphics and Computer assisted Radiology and Surgery

Diploma Thesis: 3D Engine for Simulation of Surgical Workflows @ ICCAS Leipzig (Innovation Center for Computer Assisted Surgery)

Einsatzorte

Einsatzorte

Düsseldorf (+50km) Hamburg (+50km) Zürich (+50km)
Deutschland, Schweiz
möglich

Projekte

Projekte

2019 - 2019: Custom Made Applications

Role: Capgemini

Customer: Bayer (Leverkusen)

Task:

  • Custom Made Applications @ Bayer / Capgemini India
  • Interface and team coordination
  • Validation Manager for computerized systems (GxP and SOP)

2009 ? 2018: Software development according

Role: Senior Software Developer

Customer: Dr. Sennewald Medizintechnik GmbH

Task:

Treatment planning software for regional deep hyperthermia / Online thermometry using magnetic resonance imaging to guide regional deep hyperthermia treatment

Environment and technologies:

  • Software development according to the Medical Device Directive and DIN EN-ISO 62304 (Medical device software ? Software life cycle processes), DIN EN-ISO 13485 (Medical devices -- Quality management systems -- Requirements for regulatory purposes), DIN EN-ISO 14971 (Medical devices -- Application of risk management to medical devices), DIN EN ISO 62366 (Medical devices -- Application of usability engineering to medical devices).
  • Full application life-cycle.
  • Development of fully integrated project data management system to satisfy CE relevant documentation requirements.
  • MS VC++ and OpenGL
  • DCMTK (Dicom Toolkit) VTK (Visualization Toolkit)
  • DigitalMars D Javascript

2005 - 2009: Requirements Engineering

Role: Senior Developer

Customer: QualityPark Berlin (System integration and tool development)

Task:

Requirements Engineering with Serena RM for UBS / Tool development and realization / Onsite support/development for UBS in Hong Kong and Zurich / System integration for Associated Press in Cranbury, New Jersey / System integration for Nokia Siemens Networks in Helsinki Finland

Environment and technologies:
Serena RM, Serena Business Mashups (Teamtrack), MS VC++, Eclipse, IBM Rational Software Modeller (Plugin development), Oracle, MSSQL, Java, Mercury QualityCenter, ALF


2004 - 2005: Auction data acquisition

Role: Software development (Freelancer)

Customer: eBay-Client and Server for Powerseller

Task:

C# based eBay Client for Auction data acquisition / Java/Tomcat based Server for Auction transmission to eBay (eBay API)

Environment and technologies:
.NET, Apache, C#, C++, Eclipse, GUI, HTML, HTTP, InstallShield, J2SE, JDK, JSP, Java, JavaBeans, Junit, MS-Access, MS-SQL-Server, MS-Visual Studio, POP3, SMTP, SQL, SSL, Struts, Windows 2000, Windows 2003, Windows NT, Windows XP


2004 - 2004: mySQL Database

Role: Software development (Freelancer)

Customer: Geo Information System for operation planning

Task:

  • mySQL Database / XSLFO PDF Creation (Invoice printing / Operation overview)
  • Berlin map for Operation planning

Environment and technologies:
AWT, Eclipse, GUI, J2SE, JDK, Java, ODBC, OO-Analyse, OODesign, OO-Programming


2003 ? 2004: RFB (VNC)-based application server

Role: Software development (Freelancer)

Customer: Taskit GmbH Berlin (Embedded systems) / Application Server for embedded systems (PDA + LCD thin client)

Task:

RFB (VNC)-based application server for PDA?s and thin client terminals.

Environment and technologies:
Borland C++ and Win32


2000 ? 2003: Catalog System

Role: Software development (Fulltime) 

Customer: jCatalog Dortmund

Task:

  • Catalog System (Tomcat/JSP/Tag libraries/GUI)
  • XSLFO-Editor (XSLT-Stylesheets, PDF On-the-fly from SAP)
  • Workflow Engine (GUI)

Environment and technologies:
Borland JBuilder, Tomcat, XSLFO, FOP


1999 - 2000: Software development

Role: Software development (Fulltime)

Customer: Fuzzy Logic Systems Dortmund / Expert system for credit decision CCBank

Task:

Environment and technologies:
Borland C++ Builder


1998 - 1999: Software development

Role: Software development (Freelancer)

Customer: Mesacon / Transputer Interface RS422 for industrial laser scanner devices

Task:

Environment and technologies:
x86 Assembler Interface Programming RS422


1997 - 1998: Software development

Role: Software development (Freelancer)

Customer: Architecture Mappingsystem for route planning

Task:

Environment and technologies:
IBM Visual Age for C++


1996 - 1997: Software development

Role: Software development (Freelancer)

Customer: Graphitti Software Cologne / Excel clone Spreadsheet application

Task:

Environment and technologies:
VC++ OCX development


1994 ? 1996: Software development

Role: Software development (Freelancer) 

Customer: IP Communication Bochum / Web development and Interactive Catalog

Task:

Environment and technologies:
Java and Borland Delphi

Aus- und Weiterbildung

Aus- und Weiterbildung

1991

Abitur Alexander Hegius Gymnasium Ahaus (Highschool)


1991-1994

Pre-degree Computer Science Technical University Berlin


2003-2007

Degree Computer Science Technical University Berlin

Study of computer science T.U. Berlin

Main topics: Computer Graphics and Computer assisted Radiology and Surgery

Diploma Thesis: 3D Engine for Simulation of Surgical Workflows @ ICCAS Leipzig (Innovation Center for Computer Assisted Surgery)

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