Job Description

European manufacturing company seeking laser welding process for medical device

• Evaluate and accountable for laser welding manufacturing processes, NPI project and process development to product transfer and production
• Define workflow, derive acceptance criteria, prepare production transfer and release for serial production
• Monitor key performance indicators, analyze them, address deviation and initiate corrective actions
• Using statistical tools to determine failures root causes and recommend change to optimize processes
• Document new process and train production staff in new and existing methods
• Practice lean manufacturing / CI methods to optimize, reduce waste and improve manufacturing efficiency
• Design test methods and validate process requirement including IQ, PQ, OQ
• Work with internal and external stakeholders regarding procurement and process projects
• Hands on and take ownership for corrective actions as well as process changes

• Degree in Electrical, Mechanical, Mechatronics or Industrial Engineering
• 3 years of work experience in process development & validation in a medical device manufacturing environment
• Knowledge of laser technology and its operations such as laser welding, laser marking, etching
• Knowledge with analytical tools such as DOE, FMEA, SPC application
• Knowledge of lean concepts, Six sigma methodology
• Familiar with ISO13485 and GMP
• Able to use SAP, MES and Excel
• Able to travel overseas for assignment and process learning (2 - 3 months)
• Independent, hands-on, analytical, multi-task and good organizational skills