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

Fresenius Medical Care (company)


Posted on : 28 May 2017

Project Description

 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       




Career with a purpose:       
  • Over 200,000 people across the globe work at our company to provide better medicine for more people.  
  • Our independent business segments offer a wide spectrum of products and services in the health sector.  
  • We offer you the opportunity to make a difference with your career  and to become part of our impressive growth story.                    
  • our corporate culture for entrepreneurs in an enterprise  where you can quickly take on responsibility.   

Locations

61352 Bad Homburg Germany

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