Ralf Thölke

freelancer

Selbstständig, Medical Device Expert, Ralf Thölke

Abschluss: Agiles Projektmanagement, Professional Scrum Master, Professional Scrum Product Owner, indisoft

Berlin, Deutschland

Über mich

Versatile, results-oriented professional with more than 36 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.

Fähigkeiten und Kenntnisse

nursing practice
medical technology
hyperbaric medicine
cardiovascular perfusion
medical engineering
health care system
MS Office
Scrum
Hospital
Kardiotechnik
Agile Entwicklung
Medizinische Beratung
Health Technology Assessment
FDA
Militär
Summarive Evaluation
Formative Evaluaton
Use Specification
User Interface Specification
Use Scenario
User Requirement
User Needs
Simulation
Professionalität
Zielstrebigkeit
innovativ
Erfahrung
Führungserfahrung
ECMO
Herzlungenmaschine
VAD
Kontrastmittelinjektor
Perfusor
Infusomat
Beatmungsgerät
Defibrillator
Krankenpflege
Intensivmedizin
Intensivpflege
Recruitment Testpersonen
Simulation klinischer Umgebung
Patientenmonitoring
UOUP
Usability Evaluation
Risk Assessment
Vakuumassistierte venöse Drainage
Zentrifugalpumpe
Oxygenator
Usability engineering
Risk Management
Clinical Consultant
Beratung

Werdegang

Berufserfahrung von Ralf Thölke

  • Bis heute 2 Jahre und 6 Monate, seit Jan. 2022

    Medical Device Expert

    Ralf Thölke

    Medical Advisory (counseling of medical tech companies), Agile Project Management (SCRUM Master / Product Owner), Risk Management according to ISO 14971, Usability Engineering according to IEC 62366 and FDA (e.g. management of usability evaluations in clinical environment, documentation), Clinical Trainer

  • 13 Jahre, Jan. 2009 - Dez. 2021

    Manager Medical Affairs

    Maquet Cardiopulmonary GmbH / Getinge Group

  • 1 Jahr und 7 Monate, Juni 2007 - Dez. 2008

    Chief Perfusionist

    Maquet Cardiopulmonary AG

  • 13 Jahre und 11 Monate, Juli 1993 - Mai 2007

    Deputy Chief Perfusionist

    Charité Berlin
  • 3 Monate, Apr. 1993 - Juni 1993

    Perfusionist

    Asklepios Klinik St. Georg, Hamburg

  • 1 Jahr, Apr. 1992 - März 1993

    Perfusionist

    Deutsche Forschungsgemeinschaft DFG

  • 2 Jahre und 10 Monate, Juni 1987 - März 1990

    Intensive Care Nurse

    Deutsches Herzzentrum Berlin-DHZB
  • 3 Jahre und 1 Monat, Jan. 1981 - Jan. 1984

    NCO

    Bundeswehr

Ausbildung von Ralf Thölke

  • 2022 - 2022

    Agile Project Management

    indisoft

  • 2021 - 2021

    Post Market Surveillance von Medizinprodukten

    TÜV

  • 2021 - 2021

    Design und Entwicklung von Medizinprodukten

    TÜV

  • 2021 - 2021

    Risk Management ISO 14971:2019

    TÜV

  • 2021 - 2021

    Quality Management - MDR

    TÜV

  • 6 Monate, Nov. 2019 - Apr. 2020

    Health Technology Assessment

    Technische Universität Berlin

  • 1 Jahr und 4 Monate, Jan. 2015 - Apr. 2016

    Medical Devices Usability Expert

    TÜV Rheinland

  • 2012 - 2012

    Usability Expert

    Usability Academy

  • 1 Monat, Sep. 2008 - Sep. 2008

    Executive Management Training

    Maquet Training Program

  • 2006 - 2009

    Health Economy

    Apollon-University

  • 1 Jahr und 5 Monate, Okt. 1998 - Feb. 2000

    IT-Network and Telecommunication Technology

    Study Assossiation Darmstadt

  • 2 Jahre, Apr. 1990 - März 1992

    Cardiovascular Technology

    Academy for Perfusion Technology

  • 3 Jahre, Apr. 1985 - März 1988

    Advanced Program Medical Care

    Nursing School

  • 1982 - 1982

    Hyperbaric Medicine

    Technical Naval College

  • 1982 - 1982

    Military Medical Service

    Military Academy of Health Service

  • 1979 - 1980

    Administration, Business and Management

    College of Commerce

Sprachen

  • Deutsch

    -

  • Englisch

    -

  • plain language

    -

Interessen

Family
traveling
computer technology
author programmes
science reading
health care economy
cross-country skiing
bicycling

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