Theodore CleggettPrincipal-level Manufacturing and Quality Engineer

I am a Principal-level Manufacturing and Quality Engineer with over 20 years of experience supporting Class I, II, and III medical device manufacturing in highly regulated environments. My background is strongly focused on risk-based process remediation, PFMEA/DFMEA alignment, and hands-on support of manual and automated assembly operations to improve first-pass yield and reduce nonconformances. I have led numerous IQ/OQ/PQ and test method validation efforts, authored extensive CAPA investigations, and driven cross-functional corrective actions that delivered measurable yield and reliability improvements.

Recently, I supported catheter and console manufacturing lines where I performed PFMEA updates, capability studies, and shop-floor troubleshooting to close quality gaps and sustain process performance. I am particularly comfortable working directly on the production floor, partnering with Manufacturing, Quality, and Engineering to implement practical, compliant solutions that hold up under FDA and ISO scrutiny.