Technical Engineer

Role Summary

The Technical Engineer is responsible for providing technical support in manufacturing operations, process improvements, equipment validation, and product development. This role ensures that all engineering activities meet quality, safety, and regulatory standards (ISO 13485, GMP) while supporting continuous improvement initiatives in the medical device manufacturing environment.

Key Responsibilities

• Technical & Process Support
• Provide technical expertise in troubleshooting production equipment and processes.
• Monitor and analyze production performance to identify process improvements.
• Support root cause analysis and corrective / preventive actions (CAPA).
• Equipment & Maintenance
• Oversee installation, commissioning, and qualification of new equipment.
• Coordinate preventive maintenance schedules and ensure equipment reliability.
• Work with suppliers and contractors for equipment service and upgrades.
• Product & Process Development
• Assist in new product introduction (NPI) and transfer to production.
• Participate in design of experiments (DOE) and process validation.
• Ensure compliance with product specifications and regulatory requirements.
• Quality & Compliance
• Prepare and maintain technical documentation (SOPs, work instructions, reports).
• Ensure compliance with ISO 13485, GMP, and other regulatory standards.
• Support audits (internal, customer, and regulatory) with required technical data.
• Continuous Improvement
• Lead or support Lean, Kaizen, and Six Sigma projects for cost and efficiency improvements.
• Implement automation and process optimization initiatives.
• Contribute ideas to reduce downtime, defects, and waste.
• Teamwork & Training
• Provide training and technical guidance to production and maintenance teams.
• Collaborate with cross-functional departments (QA, R&D, Production, Supply Chain).

Requirements

Job Type : Full-time

Pay : RM2, RM4,642.01 per month

Benefits :

Work Location : In person