
Manufacturing Engineer
2 weeks ago
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
Requirement
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 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
Not Specified
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