Dirk Wunderle

Responsible for the Product Support team (classes Ir-III), with 10 development engineers & designers to maintain and grow local Knee and Hip product lines. Improve designs of existing Instruments and Implants, Develop product line extensions including design control documentation and submissions

Responsible for EU MDR 2017/745 submission of legacy products (classes Ir-III), leading a US team of 18 development engineers to remediate existing Design Control documentation. Delivered 39 remediated legacy projects to notified body.

Leading the European centric profit center for Custom-Made implants, specific instruments and surgeon driven innovations supporting the Hip, Knee, Trauma and Endoscopy business.

Managing/implementing the Concept Development subgroup of InVentures Endoscopy Europe/IRAMEA with two direct reports. EU Customer led product development including surgeon contracting, feasibility evaluation, prototyping, cadaver laboratory evaluation, project management, Design Controls and transition into manufacturing

Project leader and development engineer of two critical shoulder instability projects including international key KOL management, leading marketing, quality and regulatory teams with responsibility for Design Control, cadaver laboratory evaluation, Design Transfer, budget and market launch.

Internation assignment (Boston, US) - Managing the Concept Development subgroup of InVentures Endoscopy US with two direct reports including surgeon contracting, feasibility evaluation, prototyping, cadaver laboratory evaluation, project management and transition into manufacturing

Project leader and development engineer of Custom-Made implants and special instrument projects for patients and surgeons in the field of knee, hip and endoscopy. Successful design and launch of a country specific (US) Hip stem system including Project Management, Design Controls, Design Transfer, time schedule, budget and communication. On time delivery of Custom-Made implants and special instrument designs in collaboration with the surgeons or the country marketing leads

Deputy group leader Hip development department. Coordination of projects and professional leadership of engineers and mechanical design engineers. Project lead in the field of un-cemented hip prosthesis starting with the surgeon’s idea until the preparation and implementation of time and cost schedules according to the development process.

Representative group leader for the department of Minimal Invasive Surgery. Coordination of projects and professional leadership of mechanical design engineers

Vertiefungsrichtung Projektmanagement

Energietechnik