Join Dexcom as a Staff Risk Management Engineer and lead efforts to enhance product safety and regulatory compliance. This remote role emphasizes your expertise in medical device risk management. In this position, you will oversee the Risk Management File for Dexcom’s on-market products, ensuring alignment with regulatory standards such as ISO 14971 and FDA Quality System Regulation.
Your role involves leading risk analyses and collaborating with diverse product teams to drive risk management excellence across the organization. Key Responsibilities:
- Ensure Risk Management File accuracy and compliance
- Develop risk management documentation and controls
- Conduct complex assessments of risk management activities
- Support Health Hazard Evaluations post-market
- Communicate findings and recommendations to teams Requirements:
- Bachelor’s degree with 8-12 years of experience
- Expertise in ISO 14971 and EU MDR requirements
- Knowledge of FDA Quality System Regulations
- Solid understanding of risk management best practices
- Experience with post-market surveillance and root cause analysis Make a significant impact in health technology through risk management leadership at Dexcom.