Our passionate platforms team develops the future Brainlab image guide surgery and digital O.R. hardware portfolio. These innovative medical devices offer our customers easy access to the Brainlab software capabilities of today and tomorrow.
As the Certification System Designer you will be part of a highly motivated team and have the opportunity to contribute and develop your expertise by participating in our development projects. Your focus will be the integration of the latest global certification and medical device regulations into our products. As our medical regulations expert you will support our engineers during all development and certification activities and act as the first point of contact for other departments for any platform related questions about global country specific registrations and certifications (e.g. FDA, ANVISA).
Typical areas of your responsibility are:
- definition and review of technical compliance and regulatory concepts
- product requirements engineering with focus on top level and system requirements derived from global medical regulations
- management of product risk analyses for medical devices
- supervise selection and qualification of components
- coordination of internal and external developments
- analysis of technical problems and identification of solutions
- creation and assessment of the medical device product documentation
- ensure that the design planning and implementation meets global medical regulations
- definition of acceptance requirements for all top level requirements (done in close collaboration with engineers)
In this challenging position you work and actively manage the interface between the internal development team, the subject experts from various other departments, quality management and external development partners and test houses.