Lead Process Engineer: Automation & TPM

MERIT MEDICAL SINGAPORE PTE. LTD.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

MERIT MEDICAL SINGAPORE PTE. LTD. seeks a senior Process Engineering leader to drive automation and assembly improvements across the value stream. You will oversee uptime, equipment upgrades, and productivity initiatives while guiding validation and risk assessment activities.

You will collaborate with cross-functional teams to achieve OEE targets, manage budgets, and ensure compliance with cGMP, FDA regulations, ISO 13485 and ISO 14971 requirements in a medical device manufacturing setting.

Qualifications

• Degree in mechanical/electrical engineering or materials science with 5–10 years in automation.
• Experience in automation, assembly processes, and tooling/fixtures design.
• Experience in project management and validation; familiar with cGMP.
• Knowledge of FDA regulations, MDR 2017/745, ISO 13485.
• ISO 14971 risk management is an added advantage.

Responsibilities

• Lead process engineering and automation initiatives to maximize OEE.
• Ensure machine uptime and production support.
• Oversee automation upgrades and productivity projects.
• Manage yield, output, and quality; oversee PM and calibration.
• Plan equipment maintenance and risk assessment.
• Coordinate cross-functional teams to achieve equipment effectiveness.
• Drive continuous improvement to minimize disruption and savings.
• Control capital expenditure and budget.
• Ensure compliance with quality policies and environmental policies.
• Maintain safe working environment adhering to regulations.

Skills

Automation

Assembly processes

Project management

Validation

cGMP manufacturing

Quality systems

Safety compliance

Education

Bachelor's degree in mechanical/electrical engineering or materials science

Tools

Tooling designs

Job description

MERIT MEDICAL SINGAPORE PTE. LTD. seeks a senior Process Engineering leader to drive automation and assembly improvements across the value stream. You will oversee uptime, equipment upgrades, and productivity initiatives while guiding validation and risk assessment activities.

You will collaborate with cross-functional teams to achieve OEE targets, manage budgets, and ensure compliance with cGMP, FDA regulations, ISO 13485 and ISO 14971 requirements in a medical device manufacturing setting.