31.07.2026 aktualisiert
100 % verfügbar
Freelance Medical Device Consultant
Hohenlinden, Deutschland
Weltweit
Diplomingenieur (FH)Über mich
Whether you need technical project leadership, regulatory expertise, or hands-on support throughout the product lifecycle, I help turn complex challenges into practical, successful outcomes. I combine strategic thinking with a pragmatic approach and guide cross-functional teams to success.
Skills
Medizinische GeräteMedizintechnikBiomedizinische TechnikDevice ManagementISO 14971TextilindustrieValidierungstestsVerarbeitung von TextilienKlebetechnikTextilmaschinenGerätequalifizierung
Expertise and Typical Engagements
- Technical Project & Program Leadership
- Product & Process Development
- Process Validation (IQ/OQ/PQ, CSV)
- Quality Management
- Quality Engineering
- IT Integration
Business Systems
- PLM
- CAQ
- ERP
- Master Data
- Labeling
- LIMS
Regulatory
- MDR / FDA
- ISO 13485 / ISO 9001
- GxP
- Risk Management
Whether you need technical project leadership, regulatory expertise, or hands-on support throughout the product life cycle, I help turn complex challenges into practical, successful outcomes.
My experience spans product development, regulatory compliance, manufacturing, and quality management. My greatest value is as a technical program and project lead, combining strategic thinking with a pragmatic, hands-on approach to develop solutions, align stakeholders, and guide cross-functional teams to success. By bringing together technical expertise, regulatory knowledge, operational experience, and strong collaboration skills, I bridge the gap between engineering, quality, regulatory affairs, and business objectives.
Clients value my ability to integrate quickly into existing organizations, understand their processes, and become productive from day one. I build trust across disciplines, adapt to changing priorities, and take ownership where leadership is needed to keep projects on track and deliver lasting results.
Experience across implants, cardiovascular devices, respiratory devices, orthopedic products, medical textiles, and advanced materials.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2009
Sprachen
DeutschMutterspracheEnglischverhandlungssicherFranzösischGrundkenntnisse
Projekthistorie
- Medical Device Expert and operational support for Business Central Experts / Master Data Management
- Optimized supplier & product approval process for efficiency and documentation quality
- Developed and implemented a comprehensive work instruction that standardized master data and supplier approval processes across departments
- Subject Matter Expert for quality management and process engineering: CSV, process validation, equipment qualification, test methods, design transfer, risk management, production control plans
- Planed and supported validation of manual manufacturing processes and cleaning validation
- Managed complaints and CAPAs for purchasing/supplier management
- Managed internal non-conformities and CAPAs
- Analysis and documentation of labeling requirements for medical devices according to MDR 2017/745, ISO 20417, GS1, etc.
- Development and implementation of UDI labeling for reusable medical devices
- Reorganization and documentation of the relevant business and IT processes including SAP and MES interfacing
- Development and deployment of layouts for product labeling
- Standardization of Labels, Layouts and Processes across Business Units
- User Training - Software: NiceLabel, Codesoft
- Development and implementation of UDI labeling for reusable medical devices
- Reorganization and documentation of the relevant business and IT processes including SAP and MES interfacing
- Development and deployment of layouts for product labeling
- Standardization of Labels, Layouts and Processes across Business Units
- User Training - Software: NiceLabel, Codesoft