Project Manager in new product development.Overall project responsibility to lead the global project team and coordinate theindividual disciplines.Ensure project progress and achievement of timeline and financial milestones as well as reporting to the Product Steering Committee and the general management.Procurement of tools and manufacturing equipment to supply production volumes up to 3 mio pieces per year.Project and product documentation responsibility (Technical File) to warrant a compliant market introduction according to the Medical Device Directive / Regulation (MDD/MDR).Design transfer from Product Development to all involved departments.Coordination of production ramp up and product launch with suppliers and internal departments.Elaboration of the Regulatory Affairs strategy and support of product registration / introduction in 40 countries.

Development and engineering of new products and technologies related to vacuum pumps

International Project ManagementInterface between headquarter in Switzerland and the US branchCompliant medical device manufacturingVerification, validation and release of injction molded parts and processesMaintenance, cost improvements and design enhancements of injection molded partsSubject matter expert in designing injection molded partsRoot cause analysis of manufacturing and production issuesProduct introduction and phase outDesign History ManagementAdherence to a highly regulated environment

Project reporting to Senior ManagementCost reduction of high volume low cost medical devicesManaging of OQ and PQ of automation setupsSterilisation and sterile packaging validation

Manufacturing of injection mold tools