Project Lead MedTech

10/2021 – 11/2023

Remote project planning and management (team 4-25 members) of all R&D tasks for a legal name change (Trumpf Medizinsysteme to Baxter Medical Systems)
Management of the required activities at four locations (Saalfeld, Munich, Ladson (US), Taicang (PRC)) with focus on Update: DHFs, CB Reports, Labeling, Branding, Specifications of all products
Project management /supplier management / re-registration of all products (650+) worldwide (135 countries)

Medizintechnik, DIN EN ISO 13485, Microsoft Office 365, Motivation Projektteams, SAP CRM

4/2020 – 10/2021

Project planning and management of the redesign and qualification and validation of the manufacturing process at the supplier (Gerresheimer Regensburg GmbH). Preparation of documentation for FDA.
Analysis and redesign regarding Design for Manufacturing of a sterile disposable made of injection molded components (pumps for ECMO/ECLA),

Medizintechnik, DIN EN ISO 13485, Microsoft Office 365, Prozessvalidierung, Spritzgießmaschinen, Windchill (Parametric Technology Corporation)

9/2019 – 1/2020

Project planning of the development of a clean room laboratory system for the production of active immunotherapies for the patient specific treatment of cancer for a customer (BionTech).

Projektleitung / Teamleitung (IT), Microsoft Office 365, DIN EN ISO 13485, Teamcenter (Siemens PLM Software), Medizintechnik