Marcel Hinder

Design Control (ISO 13485:2016, MDR 2017/745, QSR 820.30) • Design Input, Output, V&V, Reviews • Risk Management (ISO 14971) / Usability (IEC 62366) • Statistical sampling for Design V&V • Traceability • Design Transfer (DHF/DMR/DHR) / Changes • Design History File (DHF) Design for Six Sigma (DfSS): • SIPOC • Quality Function Deployment (QFD) • TRIZ (Methodology for Creative Problem Solving) • Six Sigma • Lifetime analysis • Statistical Tolerancing • Statistical methods • Value Stream Mapping (VSM)

Heading a team of 43 quality engineering specialists Leading of four quality departments: • Quality Engineering • Metrology Engineering • Production Control & Router Auditing • Final Release & Shipment Approval SME in MDSAP (FDA, ANVISA, TGA, Health Canada, MHLW), BSi (EU) and roving audits MDR 2017/745 implementation Implementation of MES system QA for Design / Process / Transfers Corporate expert for statistical advices and trainings Strategic projects (Lean Quality, Six Sigma, QFD, Class A, OPEX)

• Leading of two quality departments (Design and Production) • Heading a team of 13 quality engineers • Lead of the Lean Quality Initiative (e.g. Q-Circle) • Responsibility for QA activities (NPI, Transfers, PME) • Corporate Procedure for statistical techniques • Review and release of all site specific process and CSV validation activities (IQ,OQ,PQ) • Member of Lean Six Sigma and Business Excellence (BEX) committee • QA lead for implementation of MES system • Support, coordination and lead of CAPAs

• In charge of all risk based quality inspection planning activities for the reconstructive business • Creation and training of local and global (G)SOP’s • Member of the lean six sigma committee • Heading a team of 3 quality engineering specialists (Recon: hip, knee and upper extremities)

• Leading, planning and budgeting of global development projects (Fitmore Hip Stem, Global Case Design) • Project Team EU Up-Classification (Class IIb to class III devices (2007/47/EC)) • Development of new Hip Implant Systems (MMC Cup, Allofit Alloclassic Line Extension) • Regulary meetings with designing surgeons • Member of Design Control (QSR 820.30) / Risk Management (ISO 14971) Committee • Support of PMS activities Patent: WO 2007039647: Date of publication: 12.April 2007

• Development of customized packaging systems used in the pharmaceutical industry • Creation of 3D CAD models, drawings and production specifications • Supplier relationship management (SRM) • Person in charge for two apprentices

- Consulting & Communication (e.g. Harvard Concept) - Non Violent Communication - Business Excellence (EFQM), ISO 9001:2008, Audits - Continuous Improvement (DoE, Six Sigma) - Leadership & Strategy (Accounting & Controlling) - Integrated Systems & Compliance

• Strategic / operative marketing, price selling strategies (marketing mix), portfolio analysis (SWOT) • Accounting, capital budgeting, controlling (e.g. discounted cash flow, IRR, NPV, ROI) • Risk Management • Management, organization and logistic • Project Management, Total Quality Management (TQM), Innovation Management, presentation techniques Master thesis: „Quality Function Deployment (QFD) – Development of a global instrument case for the medical company Zimmer Inc.“

• Product engineering, mechanical design, structural/dynamic analysis, fatigue-strength finite element analysis • Manufacturing, automation, supply chain, statistic (DoE) • Quality testing and manufacturing measurement, design methods and dimensional measurement • Material science Diploma thesis: “Needle free injection system for diabetics” Major achievement: Patent registration DE10160393: Date of publication: 18. June 2003