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