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Dipl.-Ing. Mathias Heller
Self-employed, Founder + CEO, Heller Medical GmbH
Elsau, Switzerland
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Timeline
Professional experience for Mathias Heller
Current , since Nov 2020
Freelance Project Manager MDR Remediation
Hillrom, Trumpf Medizin Systeme GmbH + Co. KG
Project Management for MDR Remediation in a global player for hospital equipment: Remediation of Technical Documentation for MDR compatibility. Implementation of MDR compatible global IFU‘s of the entire company product portfolio.
Current , since Jan 2020
Auditor for Quality Management Systems
SQS, Schweizerische Vereinigung für Qualitäts- und Managementsysteme
Auditor and Product Expert for Medical Devices: - ISO 9001 Quality Management Systems - ISO 13485 Quality Management Systems in Medical Devices - Medical Device Regulation MDR 2017/745
Current , since Nov 2019
Freelance Project Manager Branding
TRUMPF Medizin Systeme GmbH + Co. KG
Project Management as Freelancer of a rebranding project in the medtech industry (Surgical tables and infrastructure). Integration activities of product labeling and technical documentation into the US based medtech company Hillrom.
Current , since Nov 2019
Founder + CEO
Heller Medical GmbH
Consulting MedTech companies: - R&D projects - Quality systems remediation - Process Management
1 year and 1 month, Oct 2018 - Oct 2019
Freelance Projektleiter MDR
Hamilton Medical AG
Projektleitung bei der Implementierung der neuen MDR Regulierung von Medizinprodukten. Regulatory Spezialist bei zugewiesenen Entwicklungsprojekten von neuen Hamilton Medical Beatmungsgeräten.
1 year and 1 month, Apr 2017 - Apr 2018
Senior Project Manager
Biotronik VI, Bülach Switzerland
Project Management for a large next generation medical device project (TAVI Heart Valve Catheter). Coordinate development and knowledge management activities within an international organization.
7 months, Oct 2016 - Apr 2017
Freelance Projektmanagement
Diverse Auftraggeber
Temporäre Projektarbeit bei einem Industrie-Unternehmen. Ausbildung zum Projekt-Manager IPMA. Diverse aktuell laufende Weiterbildungen (Mandarin, Regulatory Affairs Management, Additive Manufacturing).
10 months, Aug 2015 - May 2016
Technischer Leiter / CTO
BW-Tec AG
Entwicklung, Produktion und Verkauf von Sondermaschinen, die weltweit für die Produktion von Kathetern eingesetzt werden.
2 years and 9 months, Nov 2012 - Jul 2015
Project Manager R&D/QA/RA
SIS Medical AG
Projektleitung Forschung und Entwicklung, Regulatory Affairs, Quality Management
1 year and 4 months, Apr 2011 - Jul 2012
Senior Manager R&D
Acrostak (Schweiz) AG
Entwicklung von Koronarkathetern
3 years and 5 months, Nov 2007 - Mar 2011
Leiter R&D / Produktion
Straub Medical AG
11 years and 8 months, Feb 1996 - Sep 2007
Director Development Spine (Wirbelsäulen-Implantate)
Zimmer GmbH
2 years and 8 months, Mar 1993 - Oct 1995
Abteilungsleiter R&D
Schneider (Europe) AG
Educational background for Mathias Heller
8 months, Apr 2015 - Nov 2015
Management in KMU
Universität St. Gallen (HSG)
5 years and 7 months, Oct 1985 - Apr 1991
Maschineningenieurwesen, Richtung A
ETH Zürich, Abt. für Maschineningenieurwesen
Biomedizinische Technik Verfahrenstechnik
Languages
German
First language
English
Fluent
French
Intermediate
Chinese
Basic