Failure Investigation Technician I
Core
Entry-level technician providing technical and process assistance for the evaluation of returned medical devices (insulin pumps) within an FDA regulated environment to determine root cause of failure.
Role type
Entry-level Failure Investigation Technician
Builds
Diagnostic data and failure analysis reports for returned Tandem Mobi and t:slim X2 insulin pumps
Domain
Medical device manufacturing / Diabetes technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Electrical and mechanical theory knowledge, interpretation of electrical schematics, verification testing of medical devices, product manufacturing history review, component level failure analysis, data documentation and trending, compliance with FDA regulations and HIPAA
Preferred skills
Experience in product development, test, and validation, familiarity with electrical and mechanical test equipment, ability to lift up to 45 pounds
Technologies
Microsoft Office, Internet
Responsibilities
Perform failure investigations of returned insulin pumps and disposable devices, conduct verification testing of returned medical devices to approved protocols, review product manufacturing history to identify lot to lot correlations, investigate component level failure analysis, interpret electrical schematics for troubleshooting, review failure analysis reports and recommend corrective actions, maintain investigation process and analyze problem logs/trends
Seniority
Entry-level, hands-on IC