Process Engineer | Pasir Gudang

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.

Job Description (JD)

• Own and maintain manufacturing processes to ensure quality, yield, and minimal downtime.
• Develop, standardize, and optimize process equipment, tooling, fixtures, jigs, and poka-yoke.
• Create and maintain manufacturing documentation, work instructions, visual aids, and acceptance criteria.

• Lead and execute process validation activities (IQ, OQ, PQ).

• Support troubleshooting, root cause analysis, and corrective actions for non-conforming materials.

• Establish and monitor SPC and process risk assessments (pFMEA).

• Train production personnel on released processes and work instructions.

• Drive continuous improvement and cost reduction initiatives using Lean and statistical tools.

Job Requirements (JR)

• Bachelors Degree in Mechanical, Electrical, Manufacturing, Industrial Engineering, or related field.
• Experience in electro-mechanical / optical assembly and testing.
• Strong knowledge of manufacturing principles, SPC, DOE, validation, and automation processes.
• Hands-on experience in process validation, equipment verification, and troubleshooting.

• Good technical writing, analytical, and problem-solving skills.

• Experience in high-volume manufacturing environment preferred.

• Knowledge of FDA QSR and ISO 13485 is a strong advantage.

• Good English communication skills and ability to work cross-functionally.

Salary Range: RM5500 - RM11000