Dräger Medical Systems
1. Throughout the development cycle, ensure that risks are identified, control measures are defined, verified and effective, according to ISO 14971 and Dräger process.
2. Responsible for creation and maintenance of Product Risk Management File, Product Risk Management Report, Clinical Risk Management Report, Review of Post Production Information, Essential Requirements Checklist, List of Critical Components.
3. Review post-market surveillance data for Dräger and competitive products, including Dräger complaint data and publicly available adverse event databases (e.g. MAUDE).
4. Solicit input from contributing disciplines such as electronics, mechanics, software, systems engineering, algorithms, product security, clinical, usability, production, service, regulatory, and user documentation.
5. Provide guidance to the other disciplines with regard to risk management in the design process.
6. Assess product non-conformities and contribute to rationale documentation for deferred defects.
7. Perform risk-benefit analyses.
8. Participate in Health Hazard Evaluations (HHEs).
Education: Bachelors degree in engineering or clinical discipline, Master’s degree a plus.
• 5+ years relevant experience in risk management for medical devices or other regulated industry
• Experience in product development and post market
• Experience in the field of patient monitoring
• A general understanding of the potential sources of risk and how to manage risk
• Proficiency with risk management tools, including FMEA, FTA and FMECA
• Knowledge of usability or human factors engineering for medical devices
• Knowledge of GMPs as defined by the FDA
• Familiarity with UL, CSA, IEC/EN and other regulatory standards
• Skilled in collaborating with multi-disciplinary teams