Job Description

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.

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.

4. 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

Education:

Degree in Mechanical, Electrical, Mechatronics, Manufacturing Engineering, or related field.

Experience:

Minimum 2-3 years of experience in manufacturing/engineering (medical device, plastic extrusion, or cleanroom environment preferred).

Skills & Competencies:

Strong knowledge of manufacturing processes and equipment. Familiarity with ISO 13485, GMP, and regulatory compliance. Proficiency in CAD software and MS Office. Strong problem-solving and analytical skills. Good project management and communication skills.
o Able to work independently and as part of a team.

Key Performance Indicators (KPIs)

Equipment uptime and reliability. Process efficiency and yield improvement. Reduction in downtime, defects, and rework. Timely completion of validation and technical projects. Compliance with safety, GMP, and ISO standards.
Job Types: Full-time, Permanent

Pay: RM2,812.49 - RM5,000.00 per month

Work Location: In person