2015 - today: Process Development - Orthopedic Devices and Medical Compression Garments

Tasks:

• Technology research
• Product and process development incl. welding (RF, ultrasonic) and bonding processes (hot melt)
• Planning and execution of tests and trials
• Process validation
• Biomedical statistics

2022 - 2023: Product Labeling - Respiratory Health Devices

Tasks:

2020 - 2021: ISO 9001 and more - OR textiles

Tasks:

• Design, implementation and certification of an ISO 9001 based QMS on MS SharePoint
• Product: fabrics for OR gowns and drapes
• Product and process development
• Coordination of testing and OEKO-Tex® certification

Skills:

lamination, coating, bonding (hotmelt PVC, PU, reactive PU)

2019 - 2019: Remediation Project ? Heart -Lung-Machines

Tasks:

• Review of manufacturing processes of heart-lung-machines 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

2017 - 2018: Online product certification and trademark licensing system ? Viscose Fibers

Tasks:

• Development of a global online trademark licensing system for ingredient branding
• Business analysis and requirements engineering
• Business process development
• Software testing and validation in agile team
• Training and system manual
• Award (auf Anfrage)

2014 - 2015: Process Development ? Chemical Protection

Tasks:

• Development of seam sealing process (hot melt)
• Evaluation of alternative processes and materials
• Implementation and validation of process in far east manufacturing site according to customer specifications
• Products successfully launched in 2015

2010 - 2014: Product and Process Development - Mesh based Implants

Tasks:

• Design requirements analysis and implant development incl. modeling of mechanical stress
• Development and validation of test methods
• Support for design and application FMEAs
• Support for design validation
• Process development and validation incl. IQ, OQ, PQ, Design of Experiments, risk analysis, pFMEA
• Implant manufacturing incl. cutting (laser), sewing
• Mesh manufacturing incl. winding, knitting, curing, storage (vacuum), cutting, welding
• Work instructions, training
• Products successfully launched:
• ETHICON ARTISYN? Y-Shaped Mesh
• ETHICON PHYSIOMESH? Open

1997 - 2009: Quality Engineering GORE-TEX® Fabrics

Customer: W.L. Gore & Associates GmbH

Tasks:

• Quality Management TOF
• European Leader Seam Sealing Projects (selection)
• Global integrated LIMS for QC and QA (Labware)
• QM System in accordance with ISO 9001:2000
• GORE-TEX® Seam Sealing Machine

Manufacturing of Waterproof Gear

Tasks:

• Consulting/workshops on seam sealing, RF welding, hot melt bonding, construction, quality control and assurance
• Prototype manufacturing and testing
• Process and product development
• Repairs and individual repair processes