- 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
- 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.