Job Description

Company Background:

A global medical technology company specializing in innovative noninvasive monitoring solutions and advanced healthcare technologies. The organization is committed to improving patient outcomes and reducing the cost of care by developing cutting-edge devices and systems used in hospitals, clinics, and homecare settings. With operations in Malaysia, it supports engineering, manufacturing, and R&D activities, adhering strictly to international standards.

• Ensure molding production equipment and machinery in the plant achieves minimum machine downtime and obtains minimum NCR.
• Provide engineering support to Production, Engineering and QC in terms of process improvement, repairs, troubleshooting of automation and control system, calibration and process validation.
• Carry out the change request and evaluate the change effects on validated process.
• Participate in cost reduction, cost saving, carrier set-up and carrier spare parts. Improve efficiency of carrier maintenance time.
• Investigate the process and quality failure resulting from equipment/process related problems and provide permanent solution to fix them.
• Provide coaching and training to technicians on the carrier service and repair activities.
• Motivate and cultivate positive mindset and ethics among engineering associates and optimize individual performance to the company.
• Out-source and evaluate new technological innovations which lead to an increase of machines efficiency and product quality.
• Design and write engineering study protocol and execute the protocols which include data collection, analysis and provide recommendation if further improvement is required.
• Design and write URS and FDS technical documents for molding production equipment.
• Ensure all maintenance SOPs and documentation are in compliance with OSHA, ISO 13485, GxP and US regulations.
• Ensure updated release documents are changed, reviewed and approved before implementation of validation and must remain in validated state.
• Ensure all the maintenance records are properly managed.
• Promote effective communication with associates across all shifts and ensure efficient shift hand-over and effective start-up meetings.
• Ensure full compliance with Health Safety and Environment Standards.

Job Requirement

• Minimum 5 years experience in automation, control systems, process engineering, equipment installation/maintenance, and calibration in high-volume manufacturing (electronics, plastic molding, medical device, or pharmaceutical preferred).
• Diploma or Bachelors Degree in Engineering (Mechanical, Electrical, Mechatronics, or related field)
• Strong knowledge of injection molding machines, mold setup, scientific molding methodology, and peripheral equipment (dryers, controllers, robots, etc.).
• Familiar with QMS, GMP, ISO 13485, and US FDA Part 820 compliance.
• Good skills in troubleshooting, validation, statistical analysis, and use of measuring tools (calipers, micrometers, GD&T).
• Proficient in PLC/PC-based machines and MS Office.
• Strong problem-solving, communication, and interpersonal skills.
• Education: High School/Technical Certificate minimum; Diploma or Bachelors Degree in Engineering preferred.
• Willing to work in both office and production floor; occasional travel required; valid driving license.

Location: Pasir Gudang, Johor

Salary Range: RM4k - RM8k

PIC Contact No.: +6012-526 2679 (Cassandra)