Medical Devices ; Life Cycle Engineering; Projekt Management; Process Validation; Equipment Qualification; Technical Documentation
Aktualisiert am 24.06.2026
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Verfügbar ab: 01.10.2026
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davon vor Ort: 100%
Life Cycle Engineering
Technical Management
Teamleading
Validierung
Installation Qualification
Operational Qualification
Performance Qualification
Lieferantenmanagement
Technical Documentation
Englisch
Verhandlungssicher

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

3 Jahre 5 Monate
2023-02 - heute

Managing of Design Change related Projects

Technical Product Owner Temperature Devices
Technical Product Owner Temperature Devices
  • Managing of Design Change related Projects 
  • Resource Management  
  • Reporting to Top Management  
  • Overall responsibility of temperature devices Class2b
Maquet Cardiopulmonary GmbH ? Rastatt (DE)
1 Jahr 2 Monate
2022-01 - 2023-02

Supervision of change management and its correct implementation

Interims Teamlead Life Cycle Engineering
Interims Teamlead Life Cycle Engineering
  • Management and development of a team of 18 employees and 3 working students 
  • Supervision of change management and its correct implementation 
  • Coordination and evaluation of complaint investigations 
  • Cross-departmental coordination of projects & design changes 
  • Coordination with Management, Suppliers etc. 
Maquet Cardiopulmonary GmbH ? Rastatt (DE)
2 Jahre
2021-01 - 2022-12

Review of technical content in existing documentation

Technical writer for cloud-based data transfer
Technical writer for cloud-based data transfer
  • Review of technical content in existing documentation 
  • Evaluation of technical content in service documentation 
  • Data transfer - cloud based 
Roche Diagnostics - Penzberg
4 Monate
2021-10 - 2022-01

Creation and processing of work instructions

Manufacturing Engineering Consultant in the field of heart-lung machines
Manufacturing Engineering Consultant in the field of heart-lung machines

  • Creation and processing of work instructions 
  • Coordination within the project team and presentation of results  
  • Ensuring the approval processes  


Contract extension May 2018

  • Team leader for plant and equipment qualification (5 members) 
  • Qualification of production equipment  
  • Acquisition of new measuring, testing and production equipment  
  • Managing and processing the internal calibration system 
  • Ensuring the project objective 
  • Preparation and presentation of reports, deep dive meetings and presentations


Contract extension November 2018

  • Team leader process validation (4 members) 
  • Validation of production processes (bonded joints) 
  • Consultation and coordination with an external testing laboratory 
  • Ensuring the project objective 
  • Preparation and presentation of reports, deep dive meetings and presentations 
  • Elaboration of rationales 

Liva Nova GmbH (formerly Sorin Group), Project team Optimum II (FDA- and TÜV readiness) - Munich
4 Monate
2021-10 - 2022-01

Independent processing of customer documentation

Support in Supplier Quality Management/- international Manufacturing-Transfers
Support in Supplier Quality Management/- international Manufacturing-Transfers
  • Independent processing of customer documentation for FAI, Gage R&R and PPAP and Coordination with the responsible supplier 
  • Advising the project management and process planning departments in the ?Product Transfer? project 
  • Advising the project team on the preparation of technical discussions with suppliers to fulfillment of Stryker's quality requirements 
  • Advising the project manager regarding ensuring the successful and timely implementation of tasks internally and externally 
Stryker L. GmbH & Co. KG ? Freiburg (DE)
9 Monate
2021-03 - 2021-11

Creation of process validation plans & reports

Engineering Consultant - Intra ocular lenses
Engineering Consultant - Intra ocular lenses
  • Creation of process validation plans & reports 
  • Preparation of specifications (milling) 
  • Equipment qualification (production equipment) 
  • Revision of work instructions 
  • Consultation and coordination with external tool manufacturers 
Carl Zeiss MEDITEC AG ? Berlin
1 Jahr
2020-01 - 2020-12

Validation of production processes

Quality Consultant Heart Lung Machines
Quality Consultant Heart Lung Machines
  • Validation of production processes 
  • Qualification of production equipment 
  • Evaluation of measuring procedures (TMV) 
  • Carrying out incoming goods inspections 
  • Creation of standard operating procedures 
  • Audit support and presentation of own results 
Fresenius Medical Care / Xenios AG Heilbronn, Stolberg, Radeberg, Reutlingen
10 Monate
2018-02 - 2018-11

Responsibility for the installation of conveyor technology

Supervisor/ Project Manager on site Automotive (conveyor technology)
Supervisor/ Project Manager on site Automotive (conveyor technology)
  • Responsibility for the installation (PU) of conveyor technology (lifters, skids) 
  • Coordination with end customer on site 
  • Technical monitoring of work progress  
  • Safety responsibility for more than 10 employees 
  • Implementation of short-term change requests in a complex project 
  • Adherence to and management of the project budget 
Schramm GmbH at Audi AG Ingolstadt
10 Monate
2017-02 - 2017-11

remediation Project (FDA/ TÜV)

Quality Consultant in the field of Heart Lung Machines
Quality Consultant in the field of Heart Lung Machines
  • Creation and processing of work instructions 
  • CAPAS support  
  • Processing of NCs (FDA) 
  • Interface function between R&D, QA & Operation 
Maquet Cardiopulmonary GmbH - Hechingen

Aus- und Weiterbildung

Aus- und Weiterbildung

3 Jahre 5 Monate
2011-09 - 2015-01

Wirtschaftsingenieurwesen Bachelor

Technische Hochschule Deggendorf (THD)
Technische Hochschule Deggendorf (THD)
2 Jahre 4 Monate
2009-03 - 2011-06

Handwerksmeister KFZ ? Fachrichtung Motorradtechnik / Technischer Fachwirt / Ausbildung der Ausbilder (AdA)

Handwerkskammer Oberbayern
Handwerkskammer Oberbayern

Kompetenzen

Kompetenzen

Top-Skills

Life Cycle Engineering Technical Management Teamleading Validierung Installation Qualification Operational Qualification Performance Qualification Lieferantenmanagement Technical Documentation

Produkte / Standards / Erfahrungen / Methoden

IT-Kenntnisse

MS Office

  • Word 
  • Excel  
  • Power Point 


Daten Management Systeme

  • Master Control 
  • DMR 


Projekt Management Tools

  • Sci Forma 
  • MS Project 


Sonstige

  • SAP-Grundkenntnisse  


BERUFSERFAHRUNG

11/2016 - heute

Rolle: Geschäftsführender Gesellschafter

 

Aufgaben:

  • Consultant Medical Devices 
  • Projektleiter Anlagenbau in der Automobilindustrie  


06/2016 - 11/2016

Rolle: Geschäftsführender Gesellschafter

 

Aufgaben:

  • Veranstaltungsplanung 
  • Kundenakquise 
  • Mitarbeiterführung 


02/2015 - 11/2016

Rolle: Mitarbeiter

Kunde: SAS Engineering GmbH


Aufgaben:

  • Supervisor/ Projektleiter im Anlagenbau (Fördertechnik allgemein) 


06/2010 - 12/2010

Rolle: Mitarbeiter

Kunde: Schanzer Motostore


Aufgaben:

        • Werkstattmeister Motorradtechnik 
        • Fehlerdiagnose, Service und Reparatur Motorrädern 
        • Kundenbetreuung und Beratung  
        • Ausbilder (AdA) 


        06/2009 - 09/2009

        Rolle: Mitarbeiter

        Kunde: Quad und Motorradcenter Hielscher


        Aufgaben:

            • Werkstattmeister Motorradtechnik 
            • Fehlerdiagnose, Service und Reparatur von Motorrädern 
            • Kundenbetreuung und Beratung  
            • Ausbilder (AdA) 


            03/2009 - 06/2009

            Rolle: Mitarbeiter

            Kunde: Motorradhaus Stahl


            Aufgaben:

              • Fehlerdiagnose, Service und Reparatur von Motorrädern 
              • Kundenbetreuung und Beratung


              03/2005 - 03/2009

              Rolle: Auszubildender Mitarbeiter

              Kunde: Jockeys Boxenstop


              Aufgaben:

              • Fehlerdiagnose, Service und Reparatur von Motorrädern 
              • Kundenbetreuung und Beratung  
              • Sonderumbauten (Lackierarbeiten, Metallbearbeitung) 

              Einsatzorte

              Einsatzorte

              Deutschland, Schweiz, Österreich
              möglich

              Projekte

              Projekte

              3 Jahre 5 Monate
              2023-02 - heute

              Managing of Design Change related Projects

              Technical Product Owner Temperature Devices
              Technical Product Owner Temperature Devices
              • Managing of Design Change related Projects 
              • Resource Management  
              • Reporting to Top Management  
              • Overall responsibility of temperature devices Class2b
              Maquet Cardiopulmonary GmbH ? Rastatt (DE)
              1 Jahr 2 Monate
              2022-01 - 2023-02

              Supervision of change management and its correct implementation

              Interims Teamlead Life Cycle Engineering
              Interims Teamlead Life Cycle Engineering
              • Management and development of a team of 18 employees and 3 working students 
              • Supervision of change management and its correct implementation 
              • Coordination and evaluation of complaint investigations 
              • Cross-departmental coordination of projects & design changes 
              • Coordination with Management, Suppliers etc. 
              Maquet Cardiopulmonary GmbH ? Rastatt (DE)
              2 Jahre
              2021-01 - 2022-12

              Review of technical content in existing documentation

              Technical writer for cloud-based data transfer
              Technical writer for cloud-based data transfer
              • Review of technical content in existing documentation 
              • Evaluation of technical content in service documentation 
              • Data transfer - cloud based 
              Roche Diagnostics - Penzberg
              4 Monate
              2021-10 - 2022-01

              Creation and processing of work instructions

              Manufacturing Engineering Consultant in the field of heart-lung machines
              Manufacturing Engineering Consultant in the field of heart-lung machines

              • Creation and processing of work instructions 
              • Coordination within the project team and presentation of results  
              • Ensuring the approval processes  


              Contract extension May 2018

              • Team leader for plant and equipment qualification (5 members) 
              • Qualification of production equipment  
              • Acquisition of new measuring, testing and production equipment  
              • Managing and processing the internal calibration system 
              • Ensuring the project objective 
              • Preparation and presentation of reports, deep dive meetings and presentations


              Contract extension November 2018

              • Team leader process validation (4 members) 
              • Validation of production processes (bonded joints) 
              • Consultation and coordination with an external testing laboratory 
              • Ensuring the project objective 
              • Preparation and presentation of reports, deep dive meetings and presentations 
              • Elaboration of rationales 

              Liva Nova GmbH (formerly Sorin Group), Project team Optimum II (FDA- and TÜV readiness) - Munich
              4 Monate
              2021-10 - 2022-01

              Independent processing of customer documentation

              Support in Supplier Quality Management/- international Manufacturing-Transfers
              Support in Supplier Quality Management/- international Manufacturing-Transfers
              • Independent processing of customer documentation for FAI, Gage R&R and PPAP and Coordination with the responsible supplier 
              • Advising the project management and process planning departments in the ?Product Transfer? project 
              • Advising the project team on the preparation of technical discussions with suppliers to fulfillment of Stryker's quality requirements 
              • Advising the project manager regarding ensuring the successful and timely implementation of tasks internally and externally 
              Stryker L. GmbH & Co. KG ? Freiburg (DE)
              9 Monate
              2021-03 - 2021-11

              Creation of process validation plans & reports

              Engineering Consultant - Intra ocular lenses
              Engineering Consultant - Intra ocular lenses
              • Creation of process validation plans & reports 
              • Preparation of specifications (milling) 
              • Equipment qualification (production equipment) 
              • Revision of work instructions 
              • Consultation and coordination with external tool manufacturers 
              Carl Zeiss MEDITEC AG ? Berlin
              1 Jahr
              2020-01 - 2020-12

              Validation of production processes

              Quality Consultant Heart Lung Machines
              Quality Consultant Heart Lung Machines
              • Validation of production processes 
              • Qualification of production equipment 
              • Evaluation of measuring procedures (TMV) 
              • Carrying out incoming goods inspections 
              • Creation of standard operating procedures 
              • Audit support and presentation of own results 
              Fresenius Medical Care / Xenios AG Heilbronn, Stolberg, Radeberg, Reutlingen
              10 Monate
              2018-02 - 2018-11

              Responsibility for the installation of conveyor technology

              Supervisor/ Project Manager on site Automotive (conveyor technology)
              Supervisor/ Project Manager on site Automotive (conveyor technology)
              • Responsibility for the installation (PU) of conveyor technology (lifters, skids) 
              • Coordination with end customer on site 
              • Technical monitoring of work progress  
              • Safety responsibility for more than 10 employees 
              • Implementation of short-term change requests in a complex project 
              • Adherence to and management of the project budget 
              Schramm GmbH at Audi AG Ingolstadt
              10 Monate
              2017-02 - 2017-11

              remediation Project (FDA/ TÜV)

              Quality Consultant in the field of Heart Lung Machines
              Quality Consultant in the field of Heart Lung Machines
              • Creation and processing of work instructions 
              • CAPAS support  
              • Processing of NCs (FDA) 
              • Interface function between R&D, QA & Operation 
              Maquet Cardiopulmonary GmbH - Hechingen

              Aus- und Weiterbildung

              Aus- und Weiterbildung

              3 Jahre 5 Monate
              2011-09 - 2015-01

              Wirtschaftsingenieurwesen Bachelor

              Technische Hochschule Deggendorf (THD)
              Technische Hochschule Deggendorf (THD)
              2 Jahre 4 Monate
              2009-03 - 2011-06

              Handwerksmeister KFZ ? Fachrichtung Motorradtechnik / Technischer Fachwirt / Ausbildung der Ausbilder (AdA)

              Handwerkskammer Oberbayern
              Handwerkskammer Oberbayern

              Kompetenzen

              Kompetenzen

              Top-Skills

              Life Cycle Engineering Technical Management Teamleading Validierung Installation Qualification Operational Qualification Performance Qualification Lieferantenmanagement Technical Documentation

              Produkte / Standards / Erfahrungen / Methoden

              IT-Kenntnisse

              MS Office

              • Word 
              • Excel  
              • Power Point 


              Daten Management Systeme

              • Master Control 
              • DMR 


              Projekt Management Tools

              • Sci Forma 
              • MS Project 


              Sonstige

              • SAP-Grundkenntnisse  


              BERUFSERFAHRUNG

              11/2016 - heute

              Rolle: Geschäftsführender Gesellschafter

               

              Aufgaben:

              • Consultant Medical Devices 
              • Projektleiter Anlagenbau in der Automobilindustrie  


              06/2016 - 11/2016

              Rolle: Geschäftsführender Gesellschafter

               

              Aufgaben:

              • Veranstaltungsplanung 
              • Kundenakquise 
              • Mitarbeiterführung 


              02/2015 - 11/2016

              Rolle: Mitarbeiter

              Kunde: SAS Engineering GmbH


              Aufgaben:

              • Supervisor/ Projektleiter im Anlagenbau (Fördertechnik allgemein) 


              06/2010 - 12/2010

              Rolle: Mitarbeiter

              Kunde: Schanzer Motostore


              Aufgaben:

                    • Werkstattmeister Motorradtechnik 
                    • Fehlerdiagnose, Service und Reparatur Motorrädern 
                    • Kundenbetreuung und Beratung  
                    • Ausbilder (AdA) 


                    06/2009 - 09/2009

                    Rolle: Mitarbeiter

                    Kunde: Quad und Motorradcenter Hielscher


                    Aufgaben:

                        • Werkstattmeister Motorradtechnik 
                        • Fehlerdiagnose, Service und Reparatur von Motorrädern 
                        • Kundenbetreuung und Beratung  
                        • Ausbilder (AdA) 


                        03/2009 - 06/2009

                        Rolle: Mitarbeiter

                        Kunde: Motorradhaus Stahl


                        Aufgaben:

                          • Fehlerdiagnose, Service und Reparatur von Motorrädern 
                          • Kundenbetreuung und Beratung


                          03/2005 - 03/2009

                          Rolle: Auszubildender Mitarbeiter

                          Kunde: Jockeys Boxenstop


                          Aufgaben:

                          • Fehlerdiagnose, Service und Reparatur von Motorrädern 
                          • Kundenbetreuung und Beratung  
                          • Sonderumbauten (Lackierarbeiten, Metallbearbeitung) 

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