Job description
- Plan and execute product risk management activities together with the project management in an agile development and operations environment.
- Work with cross functional teams to identify and evaluate potential safety risks and develop risk mitigation measures for hazardous situations which could occur in the use of the medical devices, health software products and components.
- Track the implementation of mitigations in close collaboration with product development teams to ensure the effectiveness of the risk control measures.
- Analyze various industry and regulatory sources of information for potentially applicable risks.
- Participate in the development and review of the product design inputs and outputs with a focus on risk management.
- Maintain the contents of the product risk management files.
- Participate in internal and external audits or assessments.
- Support continuous growth in excellence of our risk management community and our risk management processes.
Qualification And Experience:
- Master s degree in engineering or Medical-Technical expert with professional project experience and a sound software background.
- 15+ years of experience in the medical device industry. Experience in SaMD (Software as a Medical Device) is preferred.
- You have multi-year experience in the usage of medical devices in a clinical environment, or risk management or project management experience in the development of software.
- You have methodological and practical experience in risk management for medical device and health software.
- You know relevant standards and regulations of risk management, e.g., MDR, ISO 14971, IEC 62304, IEC 82304, ISO 13485, ISP 62366.
- You have experience in working with international teams. A high degree of skill in both written and spoken English is required
- You have strong communication skills, are assertive and self-motivated with strong analytical and critical thinking skills.
