Mechanical Engineer

📋 Description Role based in China working remotely with travel to supplier sites (Shenzhen/Guangdong and Suzhou). Lead validation efforts, perform process audits, and manage technical documentation with supplier Regulated environment exposure (ISO 13485 or FDA 21 CFR Part 820) and collaboration with Chinese Essential functions include driving process validations, optimizing contract/component Note: job duties may change at any time with or without notice. 🎯 Requirements B.S. in Mechanical Engineering or closely related field 5+ years manufacturing or process engineering in regulated medical device or life sciences Hands-on process validation (IQ/OQ/PQ) per FDA 21 CFR Part 820 / ISO 13485; supplier audits and Proficiency reading engineering drawings (GD&T, tolerancing); SPC/CpK/Ppk Experience with pFMEA, control plans, validation docs; familiarity with PLM/QMS Native or near-native Mandarin; professional English