Sr Product Surveillance Engineer - Software QA

$95,900 – $159,900 · Posted 10 days ago

San DiegoLast seen 8 days ago

Summary

Sr Product Surveillance Engineer responsible for investigating postmarket software and device issues, driving complaint investigation processes, and ensuring regulatory compliance for medical devices. The role requires deep understanding of Dexcom's software architecture to evaluate product performance, apply structured problem-solving and statistical analysis to root-cause investigations, and communicate findings to technical and non-technical stakeholders. You will support quality system activities (CAPA, HHEs), conduct software risk assessments, and partner with product and quality teams to translate postmarket insights into product improvements. Success requires demonstrated knowledge of FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, and medical device quality systems.

Quality Assurance Capa Cloud Based Platforms Data Driven Applications Dfmea Distributed Systems Eu Mdr Fda 21 Cfr Part 820 Iec 62304 Iec 82304 Iso 13485 Iso 14971 Pfmea Postmarket Surveillance Risk Assessment Risk Management Root Cause Analysis Software Architecture Statistical Analysis