Location
Schweinfurt | Germany
Job description
In your role as Risk Manager (m/f/d) you will be responsible for the entire product risk management of medical devices.
Your assignments
- Responsible for the planning and implementation of risk management, the creation and updating of the risk analysis for medical devices while complying with the relevant standards (e.g. ISO14971)
- In charge for the specification of counter measures (requirement management)
- Work in cross functional teams with engineers, medical-experts, human factors engineers, project manager etc.
- Ensuring that all activities related to risk management are carried out in accordance with the risk management plan
- Accountable for the risk management transfer into production units
- Planning and monitoring of risk assessments and transferring relevant contents into the risk analysis
- Responsible for the reconciliation of risk analysis and pre-production defect management (anomaly reports)
- Support the creation of FMEAs and anomaly reports
- Create Risk Analysis and the Risk Management Report and ensure that risk management files are up to date
Your profile
- Bachelor or master’s degree in engineering or a similar technical field required, such as medical technology or a technical apprenticeship with further training to be a technician, along with relevant professional experience
- Several years of work experience in risk management in controlled industry (medical devices, automotive, aerospace, etc.) or in field of research and development
- Passion to perform in-depth technical reviews
- Deep knowledge of ISO 14971 (risk management for medical devices)
- Good knowledge of how to apply risk management activities
- Experienced with product or design and development
- Basic knowledge of FMEA methods as well as basic knowledge of functional and design-related safety
- Familiar with durables and disposables of medical devices
- Fluent in written and spoken English, German language is nice to have
- Willingness to travel national and international
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Job tags
Salary
