R&D Engineer, GxP/MedTech

GxP‑ & Medizintechnik‑Engineer mit unfair viel Erfahrung: R&D, QA, RA, Produktion und Praxis – von Elektronik und Maschinenbau über Biomedizintechnik bis Labor und Reinraum, strukturiert und auf den Punkt gebracht.

• Data Science / Python
• Elektronik/Maschinenbau/Automatisierung
• Entwicklungsprozesse <> Projektmanagement
• FMEA (Failure Mode and Effects Analysis)
• GAMP
• GxP/MDR/IVDR
• Optoelektronik/Messtechnik
• Requirement, Test and Project Management, Polarion
• Systems Engineering (EA)
• Validieren, Verifizieren, Testen, Dokumentieren

I am an experienced technical developer, manager, and entrepreneur with a strong focus on medical technology. From the initial idea through to CE certification, I have successfully developed a Class II medical device, built a company, and later transferred it to a larger corporation. Today, I apply the knowledge and experience gained from this journey in a wide range of hands on technical consulting projects.
My core areas of expertise are mechanical engineering, electrical engineering, and data science, complemented by extensive experience in MDR , GMP , and standards compliant development, verification, and validation processes. I place great value on creating technical solutions that are not only properly documented, but also practical and economically viable.
I work in a structured and pragmatic manner, lead interdisciplinary teams with a calm and steady approach, and maintain a clear overview even in complex technical and regulatory environments. My goal is to turn demanding boundary conditions into robust, market ready products and efficient processes.

GMP, GAMP, ISO13485
Clean-Room & Process-Development
Testing, Verification, Validation, Qualification
Requirement-Engineering
Project-&Testmanagment
Polarion
Python, Labview, C/C++