Profilbild von Markus Weber Expert advisor medical device aus Jegenstorf

Markus Weber

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Letztes Update: 02.03.2022

Expert advisor medical device

Firma: mind4medical GmbH
Abschluss: Dipl Ing FH
Stunden-/Tagessatz: anzeigen
The hourly rate varies depending on the working disciplines and duration.
Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher) | französisch (Grundkenntnisse)

Dateianlagen

CV MarkusWeber_e_Mind4medical_20220222.pdf

Skills

Holistic process development for medical device development considering:
- MDR 2017/745
- 21CFR Part 820
- Risk management ISO 14971:2020 & ISO/TR 24971:2020
- Post-market surveillance ISO/TR 20416
- Quality Management ISO 13485:2016
- Usability engineering IEC 62366

Leading workshops to improve the content workflow for medical device development, get ready for digital transformation
Technical documentation reviews for medical device class I, IIa, IIb, and III
Project manager for active medical device
Build up a documentation principle for content driven documentation (CMS for doc control)

Projekthistorie

08/2020 - bis jetzt
Engineering Cunsultant
Startup in Trauma (< 10 Mitarbeiter)
Pharma und Medizintechnik
- Support in the organisation of technical documentation
- Writing technical documentation, especially test methods and verificaiton reports
- Designing of trauma implants (CAD Creo parametrics, free form surfaces)

08/2019 - bis jetzt
Expert advisor for Medical device life cycle process
several Swiss medical device company (10-50 Mitarbeiter)
- Process landscape analysis
- Assessment of the level of digitalization in product life cycle
- Workshop for process improvements

05/2019 - 12/2020
Material research
Global Company (>10.000 Mitarbeiter)
Pharma und Medizintechnik
Gap analysis for material standards:
Implant material ASTM vs ISO
Instrument material ASTM vs ISO
Gap assessment internal material specification

01/2020 - 10/2020
Chief technology officer
confidential (< 10 Mitarbeiter)
Pharma und Medizintechnik
Maintain Mircrosoft365 IT infrastructure including B2B integration and Azure AD administration
Process builder for process development (Quality managemnt)
Requirements engineering
Gap analysis as service for 
Risk management, Technical documentation, consistences check
Software evaluation
IT Security coordination

Zeitliche und räumliche Verfügbarkeit

Prefer to work remotely as much as possible and keep on-site to a minimum. This is much more efficient.

Kontaktformular

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