Risk Management Consultant, Requirements Engineering Consultant
Endoscopy
Schlagwörter
Skills
Medical Device Expert
Usability Expert IEC 62366
Risk Manager ISO 14971
SCRUM Product Owner
Clinical Consultant
A versatile, results-oriented professional with years of extensive experience in risk management, usability engineering, medical care and clinical consulting who enjoys the challenge of finding creative and resilient solutions in the highly regulated environment of medical device development. High level of technical understanding leads to his profound knowledge of the medical device being developed. Has a broad clinical background and approaches all aspects of the job with an open mind and great willingness to learn. Gladly and competently passes on acquired knowledge. Analytical thinking, sense of responsibility and initiative, coupled with own problem-solving skills and the ability to deal openly and constructively with conflicts within the team. Makes decisions or can competently contribute to them. Has a high degree of stress resistance, control ability, persuasiveness, and assertiveness.
CORE COMPETENCIES:
Risk Management, ISO 14971, IEC 62304 & Usability Engineering, IEC 62366 & Agile Project Management & Train the trainer & Team Leadership & Solutions Advice & Communication & System Requirement Specification & Business Development
Usability Expert IEC 62366
Risk Manager ISO 14971
SCRUM Product Owner
Clinical Consultant
A versatile, results-oriented professional with years of extensive experience in risk management, usability engineering, medical care and clinical consulting who enjoys the challenge of finding creative and resilient solutions in the highly regulated environment of medical device development. High level of technical understanding leads to his profound knowledge of the medical device being developed. Has a broad clinical background and approaches all aspects of the job with an open mind and great willingness to learn. Gladly and competently passes on acquired knowledge. Analytical thinking, sense of responsibility and initiative, coupled with own problem-solving skills and the ability to deal openly and constructively with conflicts within the team. Makes decisions or can competently contribute to them. Has a high degree of stress resistance, control ability, persuasiveness, and assertiveness.
CORE COMPETENCIES:
Risk Management, ISO 14971, IEC 62304 & Usability Engineering, IEC 62366 & Agile Project Management & Train the trainer & Team Leadership & Solutions Advice & Communication & System Requirement Specification & Business Development
Projekthistorie
03/2023
-
bis jetzt
Review of the risk management file
Review of Requirement engineering documents
Review of Requirement engineering documents
02/2023
-
bis jetzt
Risk Management Consultant, Usability Engineering Consultant, Requirements Engineering Consultant
robot-assisted surgery
Review of the risk management file
Review of verification and validation reports
Review of software development documentation
Review of the usability file
Review of verification and validation reports
Review of software development documentation
Review of the usability file
05/2022
-
01/2023
Risk Management Consultant, Usability Engineering Consultant
(Pharma und Medizintechnik, 500-1000 Mitarbeiter)
- Preparation and revision of risk management documentation (according to ISO14971) for both existing and new products (Polarion)
- Evaluation of product risks in coordination with project participants
- Advising R&D on risk minimizing measures Evaluation of product changes
- Consulting on permanent improvements of the risk management process
10/2021
-
04/2022
Instructor
University Clinic Charite
(Öffentlicher Dienst, 5000-10.000 Mitarbeiter)
Collection and analysis of expected knowledge transfer
Creation of the curriculum
Preparation and execution of the seminars
Creation of the curriculum
Preparation and execution of the seminars
01/2018
-
03/2021
Clinical Consultant, Risk Manager, Usability Expert
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
ECMO Device
08/2020
-
02/2021
Usability Expert
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
ECMO-System Summative Usability Evaluation FDA
01/2012
-
12/2020
Risk Manager, Clinical Consultant, Usability Expert
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Remediation of Legacy Products (e.g. Normothermia Device, VAVD, HLM, ECMO-Device, ECMO-Disposable, Centrifugal pump, Oxygenator, etc.)
09/2019
-
11/2019
Usability Expert
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Qualitative Interviews to identify user and performance requirements for ECMO-Cannulaes
01/2019
-
06/2019
Risk Manager, Usability Expert, Usability Test Leader
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Temperature Probe
06/2018
-
12/2018
Usability Expert, Usability Test Leader
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
ECMO Device Alarm Modification
07/2017
-
08/2017
Usability Test Leader
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Summative Usqability Evaluation of an ECMO Device Modification for Transport
01/2015
-
06/2016
Clinical Consultant, Usability Expert
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Adaption of a Clinical Documentation System to user requirements
01/2016
-
03/2016
Usability Expert
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Qualitative interviews to identify user and performance requirements of an Electronic Gas Blender
07/2012
-
10/2015
Clinical Consultant, Risk Manager, Usability Expert
Development of a Ventricular Assist Device
01/2015
-
03/2015
Clinical Consultant, Risk Manager, Usability Expert
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Development of a Heart-Lung-Machine
01/2013
-
07/2013
Usability Expert, Usability Test Leader
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Development of a Flow Probe
04/2012
-
05/2012
Usability Expert, Usability Test Leader
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Development of a Venous Reservoir
07/2011
-
12/2011
Clinical Consultant, Risk Manager, Usability Expert
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Development of a Disposable Set for extracorporeal CO2-Reduction
07/2010
-
06/2011
Clinical Consultant, Risk Manager, Usability Expert, Usability Test Leader
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
ECMO-Device-GUI-Modification
06/2010
-
12/2010
Developer, Clinical Consultant
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Development of a visual ECMO Simulation for Marketing issues
01/2009
-
12/2010
Clinical Consultant, Risk Manager, Usability Test Leader
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Development of a Normo- Hypothermia Device
01/2009
-
06/2010
Clinical Consultant, Risk Manager, Usability Test Leader, Animal Lab Engineer, Clinical Application Manager
Medicdal Device Industry
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Development of an ECMO-Device, an Application Concept and a Trainiing Concept
01/2009
-
06/2010
Developer, Clinical Consultant, Risk Manager, Usability Test Leader, Animal Lab Engineer
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Development of an ECMO-Disposable Set and Priming Concept
02/2008
-
02/2008
Clinical Consultant, Risk Manager
(Pharma und Medizintechnik, 5000-10.000 Mitarbeiter)
Inhouse Certification for combined usage of CE marked Medical Products
Zertifikate
Kanban
Kanban University
2023
Agiles Projektmanagement
indisoft
2022
Professional Scrum Product Owner
Scrum.org
2022
Health Technology Assessment
TU Berlin
2020
Medical Devices Usabilirty Expert
TÜV Rheinland
2016
Usability Expert
Usability Academy
2012
Reisebereitschaft
Verfügbar in den Ländern
Deutschland, Österreich, Schweiz, Großbritannien, USA, Spanien, Italien, Liechtenstein, Ungarn, Neuseeland, Frankreich, Slowakei, Belgien, Bulgarien, Dänemark, Estland, Finnland, Griechenland, Irland, Island, Israel, Jamaika, Japan, Jordanien, Kanada, Kroatien, Lettland, Litauen, Luxemburg, Malta, Marokko, Mexico, Monaco, Namibia, Niederlande, Norwegen, Peru, Polen, Portugal, Rumänien, Sambia, Saudi Arabien, Schweden, Senegal, Slowenien, Südafrika, Tadschikistan, Thailand, Tschechische Republik, Türkei, Zypern, Nigeria, Moldawien, Montenegro, Mongolei, Tansania, Samoa und Andorra
max. Reisetätigkeit 60%
