Process Engineer (Medical devices)

Private Advertiser; Singapore; On-site; SGD 80,000 - 140,000; Full time

Job summary

Private Advertiser is seeking an experienced engineer to lead process engineering activities across manufacturing operations in Singapore. The role involves driving automation projects, equipment upgrades, process validation, troubleshooting and robust project management to meet plant objectives.

The ideal candidate has 5–10 years of automation and assembly experience, with exposure to cGMP and regulatory standards relevant to medical devices or pharmaceuticals.

Qualifications

• Degree in Mechanical, Electrical Engineering, Material Science or related field.
• 5–10 years' experience in automation and assembly processes, preferably in medical device/pharmaceutical industries.
• Experience in assembly processes, automation, tooling/fixture design, project management and validation.
• cGMP manufacturing experience preferred.
• Knowledge of FDA regulations, Medical Devices Regulation, ISO 13485 and ISO 14971 is an advantage.

Responsibilities

• Lead Process Engineering activities to support manufacturing operations and achieve plant objectives.
• Lead automation projects, equipment upgrades, process validation, troubleshooting and project management.
• Improve machine uptime, equipment reliability, process capability, yield, output, quality and OEE.
• Manage preventive maintenance, calibration, equipment risk assessment and upgrade activities.
• Coordinate with cross-functional teams on TPM, process enhancement and continuous improvement projects.
• Optimize engineering resources and budget, including CAPEX planning and spending control.
• Ensure compliance with quality, safety and environmental requirements.

Skills

Automation

Process engineering

Project management

Education

Degree in Mechanical, Electrical Engineering or related field

Tools

Fixture design

Job description

Key responsibilities

• Lead Process Engineering activities to support manufacturing operations and achieve plant objectives.
• Lead automation projects, equipment upgrades, process validation, troubleshooting and project management.
• Improve machine uptime, equipment reliability, process capability, yield, output, quality and OEE.
• Manage preventive maintenance, calibration, equipment risk assessment and upgrade activities.
• Coordinate with cross-functional teams on TPM, process enhancement and continuous improvement projects.
• Optimize engineering resources and budget, including CAPEX planning and spending control.
• Ensure compliance with quality, safety and environmental requirements.

About you

• Degree in Mechanical, Electrical Engineering, Material Science or related field.
• 5-10 years' experience in automation and assembly processes, preferably in medical device/pharmaceutical industries.
• Experience in assembly processes, automation, tooling/fixture design, project management and validation.
• cGMP manufacturing experience preferred.
• Knowledge of FDA regulations, Medical Devices Regulation, ISO 13485 and ISO 14971 is an advantage.