08.11.2025 aktualisiert

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Medical Device Expert, Usability Engineering, Product Owner SCRUM (Kanban), Medical Consultant

Königs Wusterhausen, Deutschland
Deutschland +57
info: 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, Andorra
State certified engineer in cardiovascular technology
Königs Wusterhausen, Deutschland
Deutschland +57
info: 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, Andorra
State certified engineer in cardiovascular technology

Profilanlagen

CV_ess_RTHup-to-date.pdf

Skills

Medical ConsultingIEC 62366IEC 60601-1ISO 14971Risk ManagementUsabilityMedical DeviceKardiotechnikAgiles ProjektmanagementProfessional Scum Product Owner (PSP)
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:
Quality Management, ISO 13485, 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

Sprachen

DeutschMutterspracheEnglischgut

Projekthistorie

Regulatrory Affairs Consultant

Software Development Provider

Pharma und Medizintechnik

250-500 Mitarbeiter

Assessment for MDR Regulation; App for medical study support

Risk Management Consultant, Requirements Engineering Consultant

Endoscopy
Review of the risk management file
Review of Requirement engineering documents

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

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

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

Clinical Consultant, Risk Manager, Usability Expert

Pharma und Medizintechnik

5000-10.000 Mitarbeiter

ECMO Device

Usability Expert

Pharma und Medizintechnik

5000-10.000 Mitarbeiter

ECMO-System Summative Usability Evaluation FDA

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.)

Usability Expert

Pharma und Medizintechnik

5000-10.000 Mitarbeiter

Qualitative Interviews to identify user and performance requirements for ECMO-Cannulaes

Risk Manager, Usability Expert, Usability Test Leader

Pharma und Medizintechnik

5000-10.000 Mitarbeiter

Temperature Probe

Usability Expert, Usability Test Leader

Pharma und Medizintechnik

5000-10.000 Mitarbeiter

ECMO Device Alarm Modification

Usability Test Leader

Pharma und Medizintechnik

5000-10.000 Mitarbeiter

Summative Usqability Evaluation of an ECMO Device Modification for Transport

Clinical Consultant, Usability Expert

Pharma und Medizintechnik

5000-10.000 Mitarbeiter

Adaption of a Clinical Documentation System to user requirements

Usability Expert

Pharma und Medizintechnik

5000-10.000 Mitarbeiter

Qualitative interviews to identify user and performance requirements of an Electronic Gas Blender

Clinical Consultant, Risk Manager, Usability Expert

Development of a Ventricular Assist Device

Clinical Consultant, Risk Manager, Usability Expert

Pharma und Medizintechnik

5000-10.000 Mitarbeiter

Development of a Heart-Lung-Machine

Usability Expert, Usability Test Leader

Pharma und Medizintechnik

5000-10.000 Mitarbeiter

Development of a Flow Probe

Usability Expert, Usability Test Leader

Pharma und Medizintechnik

5000-10.000 Mitarbeiter

Development of a Venous Reservoir

Clinical Consultant, Risk Manager, Usability Expert

Pharma und Medizintechnik

5000-10.000 Mitarbeiter

Development of a Disposable Set for extracorporeal CO2-Reduction

Clinical Consultant, Risk Manager, Usability Expert, Usability Test Leader

Pharma und Medizintechnik

5000-10.000 Mitarbeiter

ECMO-Device-GUI-Modification

Developer, Clinical Consultant

Pharma und Medizintechnik

5000-10.000 Mitarbeiter

Development of a visual ECMO Simulation for Marketing issues

Clinical Consultant, Risk Manager, Usability Test Leader

Pharma und Medizintechnik

5000-10.000 Mitarbeiter

Development of a Normo- Hypothermia Device

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

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

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

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