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postmarket-surveillance jobs in San Diego

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

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.

San DiegoLast seen 8 days ago