Medical Device Product Labeling
HLM – Remediation Project
Development of manufacturing processes for orthopedic devices and garments
Manufacturing of chemical protection suits
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- M.Sc. Textile Engineering
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Product & Process Development, Process Validation, Test Method Validation, Business Analysis and Requirements Engineering, Product Labeling, GxP, Project Management, Quality Engineering, Agile Management, Medical Devices
Key-Facts
Extract from Previous Activities
MedTech Company, Germany
Regulatory Labeling Specialist
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
Development and deployment of layouts for product labeling
Software: NiceLabel, Codesoft
MedTech Company, Germany
Senior Product Development Engineer
Design requirements analysis
Support of implant development
Development and validation of test methods
Determination of product specifications
Support of design and application FMEAs
Support of design validation
Complete process development and validation incl. IQ, OQ, PQ, Design of Experiments, FMEA
Work instructions, training and validation documentation in customers DMS/PLC system
ERP system integration
Launch of two successful products
MedTech Company, Germany
Senior Manufacturing Process Engineer
Review of manufacturing processes of heart-lungmachines with validation requirements analysis
Retrospective validation of adhesive bonded joins
Test method review and retrospective validation
Test method development and validation
Extended statistics including DoE (Minitab)
Project Lead in international team in an agile management approach