Device Quality Engineer - Device Risk Management and Surveillance Excellence
Location
Cambridge, MA
Job Type
Full-time
Category
other-general
Posted
June 20, 2026
**Job Title** : Device Quality Engineer - Device Risk Management and Surveillance Excellence
+ Location: Cambridge, MA
**About the Job**
As Device Quality Engineer - Device Risk Management and Surveillance Excellence within our Global Device and Packaging Unit (GDPU), you will lead critical global processes for patient safety and regulatory compliance. You are accountable for maintaining and continuously improving Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes, ensuring Medical Devices and Drug-Device Combination products comply with ISO 14971, MDR, and other relevant regulations throughout their lifecycle.
You will deliver expert quality support for risk management and post-market surveillance activities across the development pipeline and post-launch lifecycle management. The role involves collaborating with cross-functional teams and external stakeholders to ensure expert evaluations on patient safety and compl...
+ Location: Cambridge, MA
**About the Job**
As Device Quality Engineer - Device Risk Management and Surveillance Excellence within our Global Device and Packaging Unit (GDPU), you will lead critical global processes for patient safety and regulatory compliance. You are accountable for maintaining and continuously improving Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes, ensuring Medical Devices and Drug-Device Combination products comply with ISO 14971, MDR, and other relevant regulations throughout their lifecycle.
You will deliver expert quality support for risk management and post-market surveillance activities across the development pipeline and post-launch lifecycle management. The role involves collaborating with cross-functional teams and external stakeholders to ensure expert evaluations on patient safety and compl...