New Product Implementation (NPI) / Process Engineer

About the role

Responsibilities:

·       As the person in charge or main contact with the head office/product development department related to the new product or changing the design and document

·       Receive information for new products and product specifications such as technical specification, drawing, BOM, SOP for Production and QC process

·       Review product specification, BOM, Drawings, and Manufacturing Requirements

·       Prepare and monitor NPI Project Timelines, milestones, and deliverables

·       Define process flow, work instruction, equipment, tools, and production parameters

·       Conduct process trial, pilot run, and line readiness assessment together with Production and QC

·       Optimize process for productivity and cost efficiency

·       Prepare process validation documentation, including IQ/OQ/PQ

·       Develop PFMEA, Control, Process Specification with Quality and Production

·       Investigate process-related defects and implement corrective action

·       Identify and implement process improvement project

·       Improve line efficiency, cycle time, and production capacity

·       Standardize successful improvement and monitor their effectiveness

·       Train production personnel on new process and work instruction

·       Coordinate engineering changes and assess their impact on process, equipment, and documentation.

Qualifications:

·    University degree in electronic, mechanic and any engineering field

·    Having 3-5 years of experience in the development or production of electronic medical products will be advantage

·    Ability to review and develop SOP and WI for new product

·    Knowledge/experience to create of BOM for product

·    Well organized, with proven project work experience and the ability to work with very tight deadlines to complete project designs and changes. Predictively estimate the project risk before the design starts and arrange appropriate treatment measures

·    Have experienced job with an international industry will be an advantage

Skills:

·       Proficiency with Microsoft Office

·       Having knowledge of ISO 9001 & ISO 13485

·       Validation Documentation & Traceability

·       Change Control & Document

·       Have good analytical thinking

·       Risk Management & Process Risk Assessment

·       Good written and spoken in English