Martin Kaufmann

• Lead the oUS Post Market Surveillance Team in Zuchwil (3 FTE's & 2 contractors) and the offshore team in Chennai India (3 contractors) • Site lead for Post Market Surveillance • Lead execution of MDR program for Post Market Surveillance • Quality Engineering Management delegate for PMS reviews, monthly trend meetings, SMT meetings, QPR meetings. • Lead trending analyses, signal assessments and product investigations.

• Generate and lead Post Market Surveillance activities including trend analyses, signal assessments and product investigations • Execute the Post Market Surveillance process with a primary focus on signal assessment and detailed investigations of potential Safety Issues and Quality Trend Events • Responsibilities within DePuy Synthes Trauma, CMF and Biomaterials to lead Post Market Surveillance activities

• Leading a team of two direct reports • Product Development team member focused on product development and life cycle management activities. • Enhance the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement. • Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes. • Support transfer to manufacturing activities both in Product Development and base business.

• Enhance the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement. • Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes. • Conduct and lead process verification and validation activities. • Provides leadership in all areas of the Quality System.

• Mentoring and training product development engineers • Patent applications • Product development of new medical instruments and implants within Hip & Pelvis, Plates & Screws including projects for Hand & Wrist as well as Knee • Maintaining and transfer of all national and international legal and regulatory requirements for the permission and registration of instruments and implants (CE and FDA) • Timeline and cost responsibility

• Patent applications • Product development of new medical instruments and implants within Hip & Pelvis, Plates & Screws including projects for Hand & Wrist as well as Knee • Mechanical and human specimen testing • Implement trainings, courses and Workshops of instrument and implant systems • Representative of Synthes in the MIOEG (Minimal Invasive Osteosynthesis Expert Group of the AO), collaborating with the PEEG (Pelvic Expert Group) and PAEG (Pediatric Expert Group)

• Project management and development of new medical instruments and implants in the business units Pediatrics, Orthopedics & Ex Fix as well as Instruments & Engineering • Maintaining and transfer of all national and international legal and regulatory requirements for the permission and registration of instruments and implants (CE) • Timeline and cost responsibility • Representative of Synthes in the MIOEG (Minimal Invasive Osteosynthesis Expert Group of the AO)

Projektleitung, Entwicklung medizinischer Instrumente und Implantate

Entwicklung & Konstruktion medizinischer Instrumente und Implantate