Process Engineer (Automation)

Merit Medical Singapore Pte. Ltd; Singapore; On-site; SGD 100,000 - 167,000; Full time

Job summary

Merit Medical Singapore Pte. Ltd is seeking an experienced Process & Automation Engineer to provide leadership in automation projects and manufacturing support.

You will guide value stream operations, optimize machine uptime, and drive process improvements across equipment qualification, validation, and TPM programs. The role requires hands-on experience in automation, process validation, and knowledge of regulatory environments (FDA/ISO).

Qualifications

• Bachelor's degree in mechanical engineering, electrical engineering, material science, or related.
• 5-10 years hands-on automation and automated assembly experience.
• Proven track record leading automation projects end-to-end.
• Experience in cGMP manufacturing environments.
• Knowledge of FDA regulations, ISO 13485, ISO 14971 is a plus.

Responsibilities

• Lead the process engineering team to support value stream objectives.
• Drive optimal machine uptime for production.
• Lead automation projects, equipment upgrades, and productivity initiatives.
• Improve yield, output, and quality; ensure PM and calibration on schedule.
• Provide engineering expertise for equipment reliability and process capability to meet OEE targets.
• Manage engineering resources and budget effectively.
• Support validation activities and provide necessary resources.
• Plan and execute equipment maintenance and upgrades with risk assessments.
• Collaborate with cross-functional teams to achieve equipment effectiveness through TPM and process validation.
• Execute continuous improvement projects to minimize disruption and boost productivity.

Skills

Automation leadership

Process validation

Troubleshooting

OEE improvement

Cross-functional teamwork

Education

Bachelors in Mechanical Engineering

Tools

Robotics

Fixture design

Equipment qualification

Process automation

Job description

About the role

The purpose of this position is to provide process and automation engineering leadership in meeting the plant's operational objectives. You will provide engineering support for value stream manufacturing operations, lead automation projects, process validation, troubleshoot equipment, and manage projects.

Key responsibilities

• Lead the process engineering team to ensure seamless support to the value stream in meeting their respective objectives

• Lead engineering initiatives to ensure optimal machine up-time is available for production

• Lead automation projects including equipment upgrade and assembly process productivity initiatives

• Lead and manage engineering efforts to improve yield, output, and quality, ensuring PM and calibration activities are completed as per schedule

• Provide engineering expertise in achieving equipment reliability and process capability to achieve desired OEE metrics

• Manage optimal deployment of engineering resources and efficient use of budget

• Lead validation activities and projects by providing necessary engineering support and resources

• Plan and execute equipment maintenance and upgrade by conducting structured equipment risk assessment and prioritization

• Work with cross-functional teams to achieve equipment effectiveness through total productive maintenance programs and process capability through process enhancement and validation

• Execute continuous improvement projects to minimize operational disruption and achieve productivity savings

About you

• Bachelor's degree in mechanical engineering, electrical engineering, material science, or a related discipline

• 5-10 years of hands-on experience in automation and automated assembly processes

• Strong hands-on experience in automation, automated assembly processes, and design/development of tooling and fixtures

• Proven track record of leading automation projects from concept to implementation, including equipment qualification and process validation

• Working knowledge of cGMP manufacturing environments

• Technical expertise in automation systems, assembly process optimization, robotics, and manufacturing automation

• Knowledge of U.S. FDA regulations, Medical Devices Regulation (EU 2017/745), ISO 13485 Quality System Standard, and ISO 14971 Risk Management is an added advantage

• Experience in the medical device or pharmaceutical industry is preferred