Engineer, Process Molding (Medical Devices)

Location: Johor Bahru, Malaysia; the role includes local travel and work in manufacturing facilities.

Company

Manufacturing organization operating in a regulated environment with molding production, quality systems, and medical-device or pharmaceutical compliance requirements.

What you will do

• Coordinate molding processes and maintain production equipment to minimize downtime and nonconformities.
• Provide engineering support for process improvement, equipment repairs, automation and control-system troubleshooting, calibration, and process validation.
• Investigate equipment- and process-related quality failures and implement permanent corrective solutions.
• Prepare engineering study protocols, collect and analyze data, and recommend further improvements.
• Develop URS and FDS technical documents and manage validated-state documentation, maintenance records, and change requests.
• Train technicians, support shift handovers, improve carrier maintenance efficiency, and evaluate new technologies for machine and product-quality improvements.

Requirements

• At least 5 years of experience with machine automation and control systems, equipment installation, start-up, operation, maintenance, calibration, and process engineering.
• Experience in high-volume food, electronics, electrical, precision plastic molding, medical-device, or pharmaceutical industries.
• Experience in a pharmaceutical or medical-device regulated environment is preferred.
• Bachelor’s degree, technical qualification, or partial college education; a bachelor’s degree in Purchasing, Operations, Business, or a related field is required in the posting.
• Valid driver’s license and ability to operate a motor vehicle for local travel.
• Ability to work in an office and manufacturing environment, including extended periods of sitting, standing, and walking.

Culture & Benefits

• Work across Production, Engineering, Quality Control, and associates on all shifts.
• Responsibilities include compliance with OSHA, ISO 13485, GxP, US regulations, health and safety standards, and the company code of conduct.
• Opportunity to coach technicians and contribute to cost reduction, process efficiency, and technology improvement.