精密制造技术工程师 （Maca）
Core
Build and manage microbial control and inspection systems for medical device manufacturing, oversee quality risk management, and lead capacity expansion and process optimization.
Role type
Senior manufacturing technology engineer (medical devices)
Builds
Medical device production lines and quality management systems
Domain
Medical devices / Manufacturing / Quality Assurance
Required skills
Microbial management, Quality risk management, Process optimization, Capacity planning, Regulatory compliance (ISO 13485, MDR, PMD), Internal/External audit management, Team leadership
Preferred skills
NMPA Class III device project experience, Sterile/Implantable device expertise, IT process integration
Technologies
Digital management systems, Quality management software
Responsibilities
Establish microbial management and inspection workflows, manage quality risk and continuous improvement, lead capacity expansion and equipment validation, optimize yield and production efficiency, conduct regulatory training
Seniority
Senior, hands-on IC with team management
