We are hiring a highly dedicated Senior/NPI Engineer who will be responsible to manage new product introduction project which will involve in process development, reverse engineering, product transfer, validation and verification activities for our Medical Device/Pharmaceutical sector.
Key Responsibilities:
- Managing NPI project based on customer requests.
- Evaluate and manage customer/supplier change request 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, establish, validate, and implement new manufacturing process (automated, semi-automated and manual).
- Design tools/die/jig/fixture for manufacturing process.
- Prepare the Bill of Material for new material.
- Assist in process cycle time calculation and line balance for new manufacturing line.
- Establish new test method for raw material and product inspection.
- Prepare required documentations & work procedures for manufacturing of new products / processes.
- Support to technical challenges from daily operation.
- Assist in validation and process improvement activities in production.
- Provide training to production staff for new process implementation.
Key Requirements:
- Degree/Post Graduate level education in Engineering or Science.
- Minimum 2-4 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.
