Experience

• > 20 years in medical device industry
• > 18 years of experience as project leader
• > 10 years in line management, thereof 7 years as Head of Development
• Operating of clean rooms according to 14644-1
• Extensive field experience in operating theatres
• 1.5 years of experience as a teacher at a private school   

Projects

• Development of medical products of classes I, Ir, Is, IIa, IIb, III, mainly hip joint implants and surgical instruments, including successful market launch and maintenance
• Fatigue tests of class III hip implants according to ISO 7206-2/4/6/8
• Tribology of artificial hip joints
• Development of products for surgical navigation
• Project manager for electro-mechanical patch pumps for liquid drug delivery
• Master’s thesis EMBA: ‚Bedarfsabklärung für eine Einzelsteril-Nachweismethode‘

Skills

• Life cycle management of medical devices
• Development and maintainance of technical files
• CE conformity assessment
• Design verification and validation of medical products including application in the field
• Definition of materials for medical devices (metals and plastics)
• Reprocessing of medical devices (class Ir) according to ISO 17664
• Cleaning, packaging and sterilisation of medical devices including transport validation (ISO 11607-1, -2, ISTA, ISO 11137-1, -2)
• Behaviour in clean rooms and sterile areas (operating theatre)
• Maintenance and optimization of Quality Management Systems according to ISO 9001 und ISO 13485, with focus on processes development/design, cleaning, packaging, sterilisation
• Supplier audits according ISO 13485
• Risk management according ISO 14971 and TR 24971
• Labelling of medical products according ISO 15223-1, -2
• Application of CAD software and FEM (finite element methods)