Ensera Hiring! Full Time NPI Engineer in Selangor - Ricebowl

The NPI Engineer is responsible for managing new product introduction project which will involve in process development, reverse engineering, product transfer, validation and verification activities for our Medical Device/Pharmaceutical sector.

Job Responsibilities:

• Managing NPI project based on customer requests and converting the customer request into internal specification.
• Develop specification of new product according to customer requirements.
• Establish the specification for new product, sustaining changes and raw material.
• Design tools, jigs, fixtures for manufacturing process, and establish, validate, and implement new manufacturing process (automated/semi-auto/manual).
• Assist in process cycle time calculation and line balance for new manufacturing line.
• Prepare key documentation including Bill of Material (BOM), test methods for raw material and product inspection, and manufacturing SOPs for new products & processes.
• Support production with troubleshooting & process optimization.
• Assist in validation and process improvement activities in production.
• Train production teams on new processes and ensure knowledge transfer.

Job Requirements:

• Degree/Post Graduate level education in Engineering or Science.
• Minimum 2 years’ working experience preferably in manufacturing or medical industry.
• Good knowledge in Project Management & Process/Product development.
• Familiar with CAD drawing/Solidworks.
• Knowledge in statistical analysis.
• Knowledge of ISO 13485 and GMP is an advantage.
• Proactive and willing to learn.
• Good written and spoken English and Bahasa Malaysia.
• Computer skill – familiar with Microsoft Office.

Are you ready to make that career shift? Trust us, this role is always on-demand and you will grow a great portfolio with us.