Tasks
- Responsibility for carrying out product-oriented patient and user risk analyses for medical devices
- Participation in the interdisciplinary preparation of risk analyses for medical devices in the context of new and further product developments; e.g. FMEA within the device development and life cycle management
- Coordination and monitoring of activities within the risk management process
- Creation, revision and monitoring of risk management reports for the assessment of product risks
- Conceptual cooperation for the continuous improvement of the risk management process for internal and external processes
- Supporting the planning, execution and evaluation of usability engineering and clinical evaluations exercises
Qualifications
- University Degree in natural sciences degree (e.g. electrical engineering, medical engineering, mechanical engineering or computer science) or similar studies
- Experience with all Risk Management activities and complete documentation for Medical Devices according to ISO 14971 are desirable
- Ability to take responsibility for complete risk management performance and documentation in new projects
- Ability to read and understand technical design documents
- Confident handling of common development management tools (Jira/Confluence, Polarion or others)
- Good knowledge of spoken and written English in an international context. German is a plus.
- Ability to present complex issues and questions in a simple, concise manner Open minded and keen to learn and develop new skills
