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Technical Project Leader (m/f) Bad Homburg Germany,  


Posted on : 28 May 2017

Project Description

/ CAREER WITH A PURPOSE / Fresenius Medical Care - Creating a future worth living. For patients. Worldwide. Every day. More than four decades of experience in dialysis, innovative research, the global leader in dialysis services and products - that is Fresenius Medical Care. freseniusmedicalcare.com Your assignments Dedicated management of an interdisciplinary project team, as part of a global product program, tasked with the development of new dialysis equipment and the ongoing development of existing dialysis equipment as well as its software and components Definition and coordination of transparent project goals involving all relevant stakeholders, specifically in the context of the planned introduction of CE-approved products into the U.S. market Member of the cross-functional team representing the Product Engineering Center Clarification of requirements and technical feasibility Project planning and control of all activities necessary to achieve project goals in compliance with the development process (CE and FDA) Development of the specification and product architecture along with responsibility for the development of the technical design Identification and monitoring of project risks as well as the definition of risk-reducing measures to maintain project goals (content/quality, time, product/project costs) Regular communication in the form of project status reports and reporting Risk management for the device in the development phase, taking the whole system into account Has overriding control of the production transition Your profile Degree in natural science or engineering (Graduate, Bachelor, Master) Several years' professional experience of managing complex technical projects in the field of research & development (R&D) Relevant experience of the requirements (21 CFR 820) and the surveillance audits of the U.S. Food and Drug Administration (FDA) Practical experience of transferring medical devices with CE approval to the U.S. market, including approval (510k) Knowledge of regulatory requirements and processes in the field of medical technology Outstanding managerial skills and excellent stakeholder management Good technical understanding combined with ability to grasp things quickly Highly independent and autonomous Outstanding decision-making and delegation skills Good communicator who can deal with conflict well Very good written and spoken knowledge of English Willingness to travel Zus

Locations

61352 Bad Homburg Germany

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