Medical Device Expert
Aktualisiert am 02.08.2026
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.10.2026
Verfügbar zu: 100%
davon vor Ort: 60%
Risk Management for Medical Devices
Usability for Medical Devices
Clinical Consultant
KIS
Scrum
Kanban
Health Technology Assessment
Design and Development
agiles Projektmanagement
IEC 62304
Clinical Evaluation
PMS
Design/Entwicklung/Konstruktion
Requirements Engineering
Compla
Reklamationsmanagement
Regulatory Affairs
Polarion
Atlassian JIRA
Englisch
Verhandlungssicher
Deutsch
Muttersprache

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

8 Monate
2025-12 - heute

Complaint Management Consultant

International Complaint Management

Complaint Management, Risk Management acc. to MDR

Defibrillator, external CPR device


Defibrillator external CPR device
International Complaint Management
Medical Device Manufacturer
2 Jahre 4 Monate
2024-04 - heute

Regulatory Affairs Consultant

Regulatory Affairs Consultant MDR FDA
Regulatory Affairs Consultant

Assessment for MDR Regulation; App for medical study support, App for therapy

recommendations, SW-Program for mental disorders

Assessment for MDR Regulation and recommendation for Business Development;

AI app for lifestyle changes based on biomarkers


Software as Medical Device (SaMD)
MDR FDA
Software Development Provider
Berlin
3 Jahre 6 Monate
2023-02 - heute

Risk Management, Usability Engineering, Requirements Engineering Consultant

Consultant Design/Entwicklung/Konstruktion Risk Produkt-Risikoanalyse ...
Consultant

Review of risk management files, review of verification and validation test

reports, review of software development documentation, review of usability files;

robotic surgery


Robotic Surgery
Design/Entwicklung/Konstruktion Risk Produkt-Risikoanalyse Usability
Service Provider Life Science
4 Jahre 6 Monate
2022-02 - heute

Usability Engineering, Risk Management

Usability Engineer, Risk Management Consultant
Usability Engineer, Risk Management Consultant

Review of the risk management file for FDA certification, review of the usability

file for FDA certification; Remote patient monitoring

Development and introduction of a usability process in a medical technology

company; robot-assisted surgery.


robot-assisted surgery
UX-Research Provider
4 Jahre 10 Monate
2021-10 - heute

SIM-Lab

Instructor Trainer
Instructor

Creation and implementation of a curriculum. Successful certification of medical

staff for emergency ECMO-Insertion and -Transport


ECMO
Trainer
University Clinic
Berlin
1 Jahr 7 Monate
2024-05 - 2025-11

Risk Management Consultant

Risk Management Consultant Produkt-Risikoanalyse ISO 14971 IEC 62366 ...
Risk Management Consultant

Improvement of the Risk Management process, Design Transfer process,

Complaint Handling process, Engineering Change process, Requirement

Engineering for the configuration of an Application Lifecycle Management (ALM)-

Plattform

Ventilator, Humidifier, Cuff pressure controller


Ventilator Humidifier Cuff pressure controller
Produkt-Risikoanalyse ISO 14971 IEC 62366 IEC 62304 FMEA FMECA D-FMEA P-FMEA Design/Entwicklung/Konstruktion Design Transfer
Medical Device Manufacturer
1 Jahr 3 Monate
2023-03 - 2024-05

Design Control

Medical Device Consultant for Design Control and Risk Management Requirements Engineering Risikomanagement Usability
Medical Device Consultant for Design Control and Risk Management

Completion of risk management for a new development. Design Control, control

of verification and validation test reports and of the stakeholder requirements

specification; insufflators, corresponding disposables.


insufflators corresponding disposables
Requirements Engineering Risikomanagement Usability
Medical Device Manufacturer
Berlin
2 Monate
2023-02 - 2023-03

Service Provicer Life Science

Risk Management Consultant, Usability Egnieering Consultant, Requirement Engineering Consultant Risikomanagement Usability FMECA ...
Risk Management Consultant, Usability Egnieering Consultant, Requirement Engineering Consultant
Review of risk management files, review of verification and validation reports, review of software development documentation, review of usability files

robotic surgery
Risikomanagement Usability FMECA FMEA D-FMEA P-FMEA Design Transfer Functional Analysis ISO 14971 IEC 62366 IEC 62304 FDA MDR
Medical Device Manufacturer
9 Monate
2022-05 - 2023-01

Power Injector

Risk Management Consultant, Usability Consultant
Risk Management Consultant, Usability Consultant
Power Injector
Hybrid
3 Jahre 3 Monate
2018-01 - 2021-03

ECMO II

CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT Risikomanagement Produkt-Risikoanalyse Usability ...
CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT
Development of an ECMO-Device
ECMO-Device
Risikomanagement Produkt-Risikoanalyse Usability Usability-Design UI-Tests GUI-Entwicklung GUI Sicherheitsanforderung Sicherheitsmanagement Technical Documentation Physik Good Clinical Practice Medizinische Geräte Medizinprodukte Healthcare Simulation Monitoringsysteme
Germany
7 Monate
2020-08 - 2021-02

FDA

USABILITY EXPERT, RISK MANAGER Produkt-Risikoanalyse Usability Usability-Design ...
USABILITY EXPERT, RISK MANAGER
ECMO-System Summative Usability Evaluation FDA
ECMO-Device
Produkt-Risikoanalyse Usability Usability-Design UI-Tests Technical Documentation Good Clinical Practice Medizinische Geräte Medizinprodukte Healthcare Biotechnik/Medizintechnik Biotechnologie
Germany, Remote
9 Jahre
2012-01 - 2020-12

Remediation

RISK MANAGER, CLINICAL CONSULTANT, USABILITY EXPERT Physik Risikomanagement Sicherheitsanforderung ...
RISK MANAGER, CLINICAL CONSULTANT, USABILITY EXPERT
Remediation of Legacy Products (e.g. Normothermia Device, VAVD, HLM, ECMO-Device, ECMO-Disposable, Centrifugal pump, Oxygenator, etc.
Legacy
Physik Risikomanagement Sicherheitsanforderung Sicherheitsmanagement GUI Good Clinical Practice Good Clinical Laboratory Practice Good Clinical Data Management Practice Reklamationsmanagement Technical Documentation Biotechnik/Medizintechnik Biotechnologie Medizinische Geräte Medizinprodukte Healthcare Usability
Germany
3 Monate
2019-09 - 2019-11

Cannulaes

USABILITY EXPERT Physik Technical Documentation Usability ...
USABILITY EXPERT
Qualitative Interviews to identify user and performance requirements for ECMO-Cannulaes
ECMO-Cannulaes
Physik Technical Documentation Usability Usability-Design UI-Tests
Europe
6 Monate
2019-01 - 2019-06

Temperature Probe

RISK MANAGER, USABILITY EXPERT, USABILITY TEST LEADER Physik Risikomanagement Usability ...
RISK MANAGER, USABILITY EXPERT, USABILITY TEST LEADER
Temperature Probe
Temperature Probe
Physik Risikomanagement Usability Usability-Design UI-Tests Good Clinical Practice Monitoringsysteme Workflow Medizinische Geräte Medizinprodukte Healthcare
Germany
8 Jahre 1 Monat
2011-01 - 2019-01

HLM II

Risk Manager, Requirement Research
Risk Manager, Requirement Research
Germany, USA
7 Monate
2018-06 - 2018-12

Alarm

USABILITY EXPERT, USABILITY TEST LEADER Risikomanagement Sicherheitsanforderung Sicherheitsmanagement ...
USABILITY EXPERT, USABILITY TEST LEADER
ECMO Device Alarm Modification
ECMO-Device
Risikomanagement Sicherheitsanforderung Sicherheitsmanagement Good Clinical Practice Medizinische Geräte Medizinprodukte Healthcare Technical Documentation
Germany
2 Monate
2017-07 - 2017-08

Transport

USABILITY TEST LEADER Usability Usability-Design UI-Tests ...
USABILITY TEST LEADER
Summative Usability Evaluation of an ECMO Device Modification for Transport
Transport Set
Usability Usability-Design UI-Tests Technical Documentation
Germany
1 Jahr 6 Monate
2015-01 - 2016-06

KIS

CLINICAL CONSULTANT, USABILITY EXPERT KIS Good Clinical Practice Good Clinical Laboratory Practice ...
CLINICAL CONSULTANT, USABILITY EXPERT
Adaption of a Clinical Documentation System to user requirements
KIS
KIS Good Clinical Practice Good Clinical Laboratory Practice Good Clinical Data Management Practice Usability Usability-Design Medizinische Geräte Medizinprodukte Healthcare
Germany, Israel
3 Monate
2016-01 - 2016-03

EGB

USABILITY EXPERT Usability Technical Documentation Good Clinical Practice
USABILITY EXPERT
Qualitative interviews to identify user and performance requirements of an Electronic Gas Blender
EGB
Usability Technical Documentation Good Clinical Practice
Europe
3 Jahre
2013-01 - 2015-12

EOLIA

CRA Good Clinical Practice Good Research Practice
CRA

EOLIA Study

Training Observation

ECMO-Device
Good Clinical Practice Good Research Practice
Europe
3 Jahre 4 Monate
2012-07 - 2015-10

VAD

CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT, USABILITY TEST LEADER Usability Usability-Design UI-Tests ...
CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT, USABILITY TEST LEADER
Development of a Ventricular Assist Device
Usability Usability-Design UI-Tests Technical Documentation Medizinische Geräte Medizinprodukte Healthcare Biotechnik/Medizintechnik Biotechnologie Physik Sicherheitsanforderung Sicherheitsmanagement Workflow Good Clinical Practice
Europe
3 Monate
2015-01 - 2015-03

HLM

CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT Usability Risikomanagement Technical Documentation ...
CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT
Development of a Heart-Lung-Machine
HLM
Usability Risikomanagement Technical Documentation Medizinische Geräte Medizinprodukte Healthcare Good Clinical Practice Physik Biotechnik/Medizintechnik Biotechnologie Antriebskonzept Sicherheitsanforderung Sicherheitsmanagement KIS
Germany, USA, Sweden
7 Monate
2013-01 - 2013-07

Flow Probe

USABILITY EXPERT, USABILITY TEST LEADER Usability Usability-Design UI-Tests ...
USABILITY EXPERT, USABILITY TEST LEADER
Development of a Flow Probe
Flow Probe
Usability Usability-Design UI-Tests Technical Documentation
Germany
2 Monate
2012-04 - 2012-05

Venous Reservoir

USABILITY EXPERT, USABILITY TEST LEADER Usability Usability-Design UI-Tests ...
USABILITY EXPERT, USABILITY TEST LEADER
Development of a Venous Reservoir
Venous Reservoir
Usability Usability-Design UI-Tests Technical Documentation
Germany
6 Monate
2011-07 - 2011-12

ECCo2R

DEVELOPER, CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT, Usability Test Leader Medizinische Geräte Medizinprodukte Healthcare ...
DEVELOPER, CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT, Usability Test Leader
Development of a Disposable Set for extracorporeal CO2-Reduction
ECCo2R
Medizinische Geräte Medizinprodukte Healthcare Usability Usability-Design UI-Tests Risikomanagement Good Clinical Practice Technical Documentation Physik Biotechnik/Medizintechnik Biotechnologie
Europe
1 Jahr
2010-07 - 2011-06

GUI-Modification

CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT, USABILITY TEST LEADER Usability Usability-Design UI-Tests ...
CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT, USABILITY TEST LEADER
ECMO-Device-GUI-Modification
ECMO Device
Usability Usability-Design UI-Tests Risikomanagement
Europe
7 Monate
2010-06 - 2010-12

ECMO simulator

DEVELOPER, CLINICAL CONSULTANT Work Domain Experience Usability
DEVELOPER, CLINICAL CONSULTANT
Development of a visual ECMO Simulation for Marketing issues
ECMO Simulator
Work Domain Experience Usability
Hechingen
1 Jahr
2010-01 - 2010-12

Normo-Hypothermia Device

Clinical Risk Manager, Usability Expert, Medical Consultant
Clinical Risk Manager, Usability Expert, Medical Consultant
Risk Management

Usability Documentation

Summative Usability Evaluation

Development: User Interface, Training Concept, Priming Concept, Alarm Concept

HCU 40
Hechingen, Test Spots and Remote
1 Jahr 3 Monate
2009-01 - 2010-03

ECMO Device

Usability Test Leader, Clinical Risk Manager, Medical Consultant
Usability Test Leader, Clinical Risk Manager, Medical Consultant
Risk Management

Usability Documentation

Summative Usability Evaluation

Development: User Interface, Training Concept, Priming Concept, Alarm Concept

Cardiohelp
Hechingen, Test Spots and Remote
1 Monat
2008-02 - 2008-02

Inhouse certification

clinical consultant, risk manager medicine physiology ETRM ...
clinical consultant, risk manager
Inhouse Certification for combined usage of CE marked Medical Products
HLM Vaporizer anesthesia gas monitor
medicine physiology ETRM clinical evaluation
University Clinic
Tübingen

Aus- und Weiterbildung

Aus- und Weiterbildung

6 Monate
2019-10 - 2020-03

Health Technology Assessment

Certification, TU Berlin
Certification
TU Berlin
Evaluation of innovative medical procedures and medical technologies
1 Monat
2012-07 - 2012-07

Usability Expert

Certification, Usability Academy
Certification
Usability Academy

Basics and Methods of Usability and User Experience

User Centered Design (ISO13407 and ISO 9241-110)

Usability Engieering Process

UX-analysis of user needs and usability Analysis Methods

Usability Evaluation and Usability Testing

Interaction Design, Touch Design and Prototyping

Cross-Cultural Usability & International User Experience

3 Jahre
1998-01 - 2000-12

IT-Administrator

Diploma, Studiengemeinschaft Darmstadt
Diploma
Studiengemeinschaft Darmstadt
2 Jahre 2 Monate
1990-03 - 1992-04

Cardiovascular Technology

state certified engineer in cardiovascular technology, Akademie für Kardiotechnik, Berlin
state certified engineer in cardiovascular technology
Akademie für Kardiotechnik, Berlin
3 Jahre 2 Monate
1985-03 - 1988-04

medical and health care

Reg. Nurse, Städtisches Krankenhaus Verden/Aller
Reg. Nurse
Städtisches Krankenhaus Verden/Aller

Position

Position

Risk Manager

Usability Expert

Medical Advisor

Kompetenzen

Kompetenzen

Top-Skills

Risk Management for Medical Devices Usability for Medical Devices Clinical Consultant KIS Scrum Kanban Health Technology Assessment Design and Development agiles Projektmanagement IEC 62304 Clinical Evaluation PMS Design/Entwicklung/Konstruktion Requirements Engineering Compla Reklamationsmanagement Regulatory Affairs Polarion Atlassian JIRA

Produkte / Standards / Erfahrungen / Methoden

IEC 62366
Experte
ISO 14971
Experte
60601-1-8
Experte
62304
Fortgeschritten

Berechnung / Simulation / Versuch / Validierung

Usability Engineering
Experte

Riskmanagement

ISO 14971
Experte

Medical Affairs

Manager
Experte

Medizinisches Marketing

Marketing
Experte

Personalverantwortung

Erfahren
Experte

Branchen

Branchen

Medizintechnik
besondere Erfahrung mit Medizingeräten die in der Herz- und Thoraxchirurgie, Intensivmedizin, Tauchmedizin, Kardiologie, Notfallmedizin, Allgemeinchirurgie und Inneren Medizin genutzt werden.

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

8 Monate
2025-12 - heute

Complaint Management Consultant

International Complaint Management

Complaint Management, Risk Management acc. to MDR

Defibrillator, external CPR device


Defibrillator external CPR device
International Complaint Management
Medical Device Manufacturer
2 Jahre 4 Monate
2024-04 - heute

Regulatory Affairs Consultant

Regulatory Affairs Consultant MDR FDA
Regulatory Affairs Consultant

Assessment for MDR Regulation; App for medical study support, App for therapy

recommendations, SW-Program for mental disorders

Assessment for MDR Regulation and recommendation for Business Development;

AI app for lifestyle changes based on biomarkers


Software as Medical Device (SaMD)
MDR FDA
Software Development Provider
Berlin
3 Jahre 6 Monate
2023-02 - heute

Risk Management, Usability Engineering, Requirements Engineering Consultant

Consultant Design/Entwicklung/Konstruktion Risk Produkt-Risikoanalyse ...
Consultant

Review of risk management files, review of verification and validation test

reports, review of software development documentation, review of usability files;

robotic surgery


Robotic Surgery
Design/Entwicklung/Konstruktion Risk Produkt-Risikoanalyse Usability
Service Provider Life Science
4 Jahre 6 Monate
2022-02 - heute

Usability Engineering, Risk Management

Usability Engineer, Risk Management Consultant
Usability Engineer, Risk Management Consultant

Review of the risk management file for FDA certification, review of the usability

file for FDA certification; Remote patient monitoring

Development and introduction of a usability process in a medical technology

company; robot-assisted surgery.


robot-assisted surgery
UX-Research Provider
4 Jahre 10 Monate
2021-10 - heute

SIM-Lab

Instructor Trainer
Instructor

Creation and implementation of a curriculum. Successful certification of medical

staff for emergency ECMO-Insertion and -Transport


ECMO
Trainer
University Clinic
Berlin
1 Jahr 7 Monate
2024-05 - 2025-11

Risk Management Consultant

Risk Management Consultant Produkt-Risikoanalyse ISO 14971 IEC 62366 ...
Risk Management Consultant

Improvement of the Risk Management process, Design Transfer process,

Complaint Handling process, Engineering Change process, Requirement

Engineering for the configuration of an Application Lifecycle Management (ALM)-

Plattform

Ventilator, Humidifier, Cuff pressure controller


Ventilator Humidifier Cuff pressure controller
Produkt-Risikoanalyse ISO 14971 IEC 62366 IEC 62304 FMEA FMECA D-FMEA P-FMEA Design/Entwicklung/Konstruktion Design Transfer
Medical Device Manufacturer
1 Jahr 3 Monate
2023-03 - 2024-05

Design Control

Medical Device Consultant for Design Control and Risk Management Requirements Engineering Risikomanagement Usability
Medical Device Consultant for Design Control and Risk Management

Completion of risk management for a new development. Design Control, control

of verification and validation test reports and of the stakeholder requirements

specification; insufflators, corresponding disposables.


insufflators corresponding disposables
Requirements Engineering Risikomanagement Usability
Medical Device Manufacturer
Berlin
2 Monate
2023-02 - 2023-03

Service Provicer Life Science

Risk Management Consultant, Usability Egnieering Consultant, Requirement Engineering Consultant Risikomanagement Usability FMECA ...
Risk Management Consultant, Usability Egnieering Consultant, Requirement Engineering Consultant
Review of risk management files, review of verification and validation reports, review of software development documentation, review of usability files

robotic surgery
Risikomanagement Usability FMECA FMEA D-FMEA P-FMEA Design Transfer Functional Analysis ISO 14971 IEC 62366 IEC 62304 FDA MDR
Medical Device Manufacturer
9 Monate
2022-05 - 2023-01

Power Injector

Risk Management Consultant, Usability Consultant
Risk Management Consultant, Usability Consultant
Power Injector
Hybrid
3 Jahre 3 Monate
2018-01 - 2021-03

ECMO II

CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT Risikomanagement Produkt-Risikoanalyse Usability ...
CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT
Development of an ECMO-Device
ECMO-Device
Risikomanagement Produkt-Risikoanalyse Usability Usability-Design UI-Tests GUI-Entwicklung GUI Sicherheitsanforderung Sicherheitsmanagement Technical Documentation Physik Good Clinical Practice Medizinische Geräte Medizinprodukte Healthcare Simulation Monitoringsysteme
Germany
7 Monate
2020-08 - 2021-02

FDA

USABILITY EXPERT, RISK MANAGER Produkt-Risikoanalyse Usability Usability-Design ...
USABILITY EXPERT, RISK MANAGER
ECMO-System Summative Usability Evaluation FDA
ECMO-Device
Produkt-Risikoanalyse Usability Usability-Design UI-Tests Technical Documentation Good Clinical Practice Medizinische Geräte Medizinprodukte Healthcare Biotechnik/Medizintechnik Biotechnologie
Germany, Remote
9 Jahre
2012-01 - 2020-12

Remediation

RISK MANAGER, CLINICAL CONSULTANT, USABILITY EXPERT Physik Risikomanagement Sicherheitsanforderung ...
RISK MANAGER, CLINICAL CONSULTANT, USABILITY EXPERT
Remediation of Legacy Products (e.g. Normothermia Device, VAVD, HLM, ECMO-Device, ECMO-Disposable, Centrifugal pump, Oxygenator, etc.
Legacy
Physik Risikomanagement Sicherheitsanforderung Sicherheitsmanagement GUI Good Clinical Practice Good Clinical Laboratory Practice Good Clinical Data Management Practice Reklamationsmanagement Technical Documentation Biotechnik/Medizintechnik Biotechnologie Medizinische Geräte Medizinprodukte Healthcare Usability
Germany
3 Monate
2019-09 - 2019-11

Cannulaes

USABILITY EXPERT Physik Technical Documentation Usability ...
USABILITY EXPERT
Qualitative Interviews to identify user and performance requirements for ECMO-Cannulaes
ECMO-Cannulaes
Physik Technical Documentation Usability Usability-Design UI-Tests
Europe
6 Monate
2019-01 - 2019-06

Temperature Probe

RISK MANAGER, USABILITY EXPERT, USABILITY TEST LEADER Physik Risikomanagement Usability ...
RISK MANAGER, USABILITY EXPERT, USABILITY TEST LEADER
Temperature Probe
Temperature Probe
Physik Risikomanagement Usability Usability-Design UI-Tests Good Clinical Practice Monitoringsysteme Workflow Medizinische Geräte Medizinprodukte Healthcare
Germany
8 Jahre 1 Monat
2011-01 - 2019-01

HLM II

Risk Manager, Requirement Research
Risk Manager, Requirement Research
Germany, USA
7 Monate
2018-06 - 2018-12

Alarm

USABILITY EXPERT, USABILITY TEST LEADER Risikomanagement Sicherheitsanforderung Sicherheitsmanagement ...
USABILITY EXPERT, USABILITY TEST LEADER
ECMO Device Alarm Modification
ECMO-Device
Risikomanagement Sicherheitsanforderung Sicherheitsmanagement Good Clinical Practice Medizinische Geräte Medizinprodukte Healthcare Technical Documentation
Germany
2 Monate
2017-07 - 2017-08

Transport

USABILITY TEST LEADER Usability Usability-Design UI-Tests ...
USABILITY TEST LEADER
Summative Usability Evaluation of an ECMO Device Modification for Transport
Transport Set
Usability Usability-Design UI-Tests Technical Documentation
Germany
1 Jahr 6 Monate
2015-01 - 2016-06

KIS

CLINICAL CONSULTANT, USABILITY EXPERT KIS Good Clinical Practice Good Clinical Laboratory Practice ...
CLINICAL CONSULTANT, USABILITY EXPERT
Adaption of a Clinical Documentation System to user requirements
KIS
KIS Good Clinical Practice Good Clinical Laboratory Practice Good Clinical Data Management Practice Usability Usability-Design Medizinische Geräte Medizinprodukte Healthcare
Germany, Israel
3 Monate
2016-01 - 2016-03

EGB

USABILITY EXPERT Usability Technical Documentation Good Clinical Practice
USABILITY EXPERT
Qualitative interviews to identify user and performance requirements of an Electronic Gas Blender
EGB
Usability Technical Documentation Good Clinical Practice
Europe
3 Jahre
2013-01 - 2015-12

EOLIA

CRA Good Clinical Practice Good Research Practice
CRA

EOLIA Study

Training Observation

ECMO-Device
Good Clinical Practice Good Research Practice
Europe
3 Jahre 4 Monate
2012-07 - 2015-10

VAD

CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT, USABILITY TEST LEADER Usability Usability-Design UI-Tests ...
CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT, USABILITY TEST LEADER
Development of a Ventricular Assist Device
Usability Usability-Design UI-Tests Technical Documentation Medizinische Geräte Medizinprodukte Healthcare Biotechnik/Medizintechnik Biotechnologie Physik Sicherheitsanforderung Sicherheitsmanagement Workflow Good Clinical Practice
Europe
3 Monate
2015-01 - 2015-03

HLM

CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT Usability Risikomanagement Technical Documentation ...
CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT
Development of a Heart-Lung-Machine
HLM
Usability Risikomanagement Technical Documentation Medizinische Geräte Medizinprodukte Healthcare Good Clinical Practice Physik Biotechnik/Medizintechnik Biotechnologie Antriebskonzept Sicherheitsanforderung Sicherheitsmanagement KIS
Germany, USA, Sweden
7 Monate
2013-01 - 2013-07

Flow Probe

USABILITY EXPERT, USABILITY TEST LEADER Usability Usability-Design UI-Tests ...
USABILITY EXPERT, USABILITY TEST LEADER
Development of a Flow Probe
Flow Probe
Usability Usability-Design UI-Tests Technical Documentation
Germany
2 Monate
2012-04 - 2012-05

Venous Reservoir

USABILITY EXPERT, USABILITY TEST LEADER Usability Usability-Design UI-Tests ...
USABILITY EXPERT, USABILITY TEST LEADER
Development of a Venous Reservoir
Venous Reservoir
Usability Usability-Design UI-Tests Technical Documentation
Germany
6 Monate
2011-07 - 2011-12

ECCo2R

DEVELOPER, CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT, Usability Test Leader Medizinische Geräte Medizinprodukte Healthcare ...
DEVELOPER, CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT, Usability Test Leader
Development of a Disposable Set for extracorporeal CO2-Reduction
ECCo2R
Medizinische Geräte Medizinprodukte Healthcare Usability Usability-Design UI-Tests Risikomanagement Good Clinical Practice Technical Documentation Physik Biotechnik/Medizintechnik Biotechnologie
Europe
1 Jahr
2010-07 - 2011-06

GUI-Modification

CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT, USABILITY TEST LEADER Usability Usability-Design UI-Tests ...
CLINICAL CONSULTANT, RISK MANAGER, USABILITY EXPERT, USABILITY TEST LEADER
ECMO-Device-GUI-Modification
ECMO Device
Usability Usability-Design UI-Tests Risikomanagement
Europe
7 Monate
2010-06 - 2010-12

ECMO simulator

DEVELOPER, CLINICAL CONSULTANT Work Domain Experience Usability
DEVELOPER, CLINICAL CONSULTANT
Development of a visual ECMO Simulation for Marketing issues
ECMO Simulator
Work Domain Experience Usability
Hechingen
1 Jahr
2010-01 - 2010-12

Normo-Hypothermia Device

Clinical Risk Manager, Usability Expert, Medical Consultant
Clinical Risk Manager, Usability Expert, Medical Consultant
Risk Management

Usability Documentation

Summative Usability Evaluation

Development: User Interface, Training Concept, Priming Concept, Alarm Concept

HCU 40
Hechingen, Test Spots and Remote
1 Jahr 3 Monate
2009-01 - 2010-03

ECMO Device

Usability Test Leader, Clinical Risk Manager, Medical Consultant
Usability Test Leader, Clinical Risk Manager, Medical Consultant
Risk Management

Usability Documentation

Summative Usability Evaluation

Development: User Interface, Training Concept, Priming Concept, Alarm Concept

Cardiohelp
Hechingen, Test Spots and Remote
1 Monat
2008-02 - 2008-02

Inhouse certification

clinical consultant, risk manager medicine physiology ETRM ...
clinical consultant, risk manager
Inhouse Certification for combined usage of CE marked Medical Products
HLM Vaporizer anesthesia gas monitor
medicine physiology ETRM clinical evaluation
University Clinic
Tübingen

Aus- und Weiterbildung

Aus- und Weiterbildung

6 Monate
2019-10 - 2020-03

Health Technology Assessment

Certification, TU Berlin
Certification
TU Berlin
Evaluation of innovative medical procedures and medical technologies
1 Monat
2012-07 - 2012-07

Usability Expert

Certification, Usability Academy
Certification
Usability Academy

Basics and Methods of Usability and User Experience

User Centered Design (ISO13407 and ISO 9241-110)

Usability Engieering Process

UX-analysis of user needs and usability Analysis Methods

Usability Evaluation and Usability Testing

Interaction Design, Touch Design and Prototyping

Cross-Cultural Usability & International User Experience

3 Jahre
1998-01 - 2000-12

IT-Administrator

Diploma, Studiengemeinschaft Darmstadt
Diploma
Studiengemeinschaft Darmstadt
2 Jahre 2 Monate
1990-03 - 1992-04

Cardiovascular Technology

state certified engineer in cardiovascular technology, Akademie für Kardiotechnik, Berlin
state certified engineer in cardiovascular technology
Akademie für Kardiotechnik, Berlin
3 Jahre 2 Monate
1985-03 - 1988-04

medical and health care

Reg. Nurse, Städtisches Krankenhaus Verden/Aller
Reg. Nurse
Städtisches Krankenhaus Verden/Aller

Position

Position

Risk Manager

Usability Expert

Medical Advisor

Kompetenzen

Kompetenzen

Top-Skills

Risk Management for Medical Devices Usability for Medical Devices Clinical Consultant KIS Scrum Kanban Health Technology Assessment Design and Development agiles Projektmanagement IEC 62304 Clinical Evaluation PMS Design/Entwicklung/Konstruktion Requirements Engineering Compla Reklamationsmanagement Regulatory Affairs Polarion Atlassian JIRA

Produkte / Standards / Erfahrungen / Methoden

IEC 62366
Experte
ISO 14971
Experte
60601-1-8
Experte
62304
Fortgeschritten

Berechnung / Simulation / Versuch / Validierung

Usability Engineering
Experte

Riskmanagement

ISO 14971
Experte

Medical Affairs

Manager
Experte

Medizinisches Marketing

Marketing
Experte

Personalverantwortung

Erfahren
Experte

Branchen

Branchen

Medizintechnik
besondere Erfahrung mit Medizingeräten die in der Herz- und Thoraxchirurgie, Intensivmedizin, Tauchmedizin, Kardiologie, Notfallmedizin, Allgemeinchirurgie und Inneren Medizin genutzt werden.

Vertrauen Sie auf Randstad

Im Bereich Freelancing
Im Bereich Arbeitnehmerüberlassung / Personalvermittlung

Fragen?

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