Reinhard Koehler

Partner / Gesellschafter, Geschäftsführer, MedSysCon Medizintechnik GmbH

Freiburg im Breisgau, Deutschland

Fähigkeiten und Kenntnisse

International Project Management
Medical Device Development
Quality and Risk Management
Medical Device Regulation
Medical Software Development
Usability Engineering
Regulatory Affairs
ISO 13485
Design Control
Validation
V&V
Consulting
ISO 14971
MDR
IEC 62304
CSV
UDI
Clinical Evaluation
Technical Documentation
Management
Geschäftsführung
Medizinprodukte
Compliance
Unternehmensführung

Werdegang

Berufserfahrung von Reinhard Koehler

  • Bis heute 6 Jahre und 5 Monate, seit Jan. 2018

    Geschäftsführer

    MedSysCon Medizintechnik GmbH
  • 3 Jahre, Jan. 2015 - Dez. 2017

    Director R&D Craniomaxillofacial (CMF)

    Stryker

    • Leading 60 employees distributed around 3 sites in US, Ireland and Germany • Managing the innovation development pipeline at Stryker CMF • Building high-performing teams/performance turnarounds • Structuring, staffing, aligning & orchestrating the medical device organization

  • 5 Jahre und 3 Monate, Okt. 2009 - Dez. 2014

    Software Manager

    Stryker

    • Project lead for development and market approval for patient-specific mandible reconstruction implants, including the associated design and logistics software • Responsible for the identification, analysis, evaluation and documentation of product-related risks for software and system medical devices according to ISO14971 • Conducting of internal and external audits (IEC 62304)

  • 6 Jahre, Okt. 2003 - Sep. 2009

    Project Manager / Team Leader

    Stryker Instruments

    • Setup and management of a team of specialists to establish a software product line approach (“core asset management”) • Establishment of a functional offshore strategy in collaboration with a service provider in New Delhi, India, with full responsibility for time, resources and budget • Draft of reusable SW components and SW interfaces based on UML/SysML and the use of established architecture models

  • 7 Jahre und 5 Monate, Mai 1996 - Sep. 2003

    Software Developer

    Stryker Instruments

    • Design and development of software solutions for computer-supported surgery and navigation for clinical use • Substantial participation in the development and market launch of the successful surgical navigation product lines Cranial and ENT • Responsible for the entire visualisation pipeline for image-based navigation systems, from image processing to image improvement, reconstruction and image registration

  • 7 Jahre und 10 Monate, Juli 1988 - Apr. 1996

    Software Developer

    strässle Informationssysteme

    • Software Design and development of mechanical CAD/CAM software systems

Ausbildung von Reinhard Koehler

  • Informatik mit Anwendungsfach Medizin

    Technische Universität Braunschweig

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

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