Process Engineer

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

JOB FUNCTION

• Lead Process engineering team to ensure seamless support to the value stream in meeting their respective objectives.
• To lead the 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 that are needed to improve yield, output and quality. Ensure the PM and calibration activities are done as per the 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 the budget.
• Lead the validation activities and projects by providing necessary engineering support and resources.
• Plan and execute equipment maintenance/ upgrade by embarking on structured equipment risk assessment and prioritization.
• Work with cross functional teams (Tech team) to achieve equipment effectiveness through total productive maintenance program and process capability through process enhancement and validation.
• Work with team to execute continuous improvement projects to minimize operational disruption and achieve productivity savings.
• Accountable for capital expenditure initiation and spending control.
• Ensure compliance with quality policies, procedures, and practices through appropriate communication, training, and education.
• Maintain a safe and healthy work environment by complying with all related safety regulations and environmental policies in the Company.

INTERACTION

Internal parties

• Required to communicate effectively with all levels of associates.

External parties

• Required to communicate with other Merit Plants, Corporate / Regional/Businesses, suppliers, subcontractors and government agencies as and when required.

JOB SPECIFICATIONS

Education:

• Minimum Degree in mechanical / Electrical engineering/ Material Science with 5-10 years’ experience in automation and assembly processes. Preferably from Medical device / Pharmaceutical industries.

Relevant Experience:

• Familiarization with assembly process, automation, tooling & fixtures designs are desired. Experience in project management; as well as validation are preferred. Working knowledge on cGMP manufacturing setting

Others:

• Technical specialization in assembly/ automation process preferred.
• Knowledge of U.S FDA regulations, the Medical Devices Regulation (2017/745), ISO 13485 Quality System

Standard, ISO 14971 Risk Management are added advantage.

• Knowledge of U.S FDA regulations, the Medical Devices Regulation (2017/745), ISO 13485 Quality System

Standard, ISO 14971 Risk Management are added advantage.