Process Engineer

Merit Medical Systems, Inc.; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

Merit Medical Systems, Inc. is seeking a Senior Process Engineer to lead a high‑performing team in a manufacturing environment. You will guide process improvements, drive automation initiatives, and ensure equipment reliability to meet OEE targets.

The role requires hands‑on leadership, project management, and familiarity with cGMP and medical device regulations. A strong focus on quality, safety, and cross‑functional collaboration is essential.

Qualifications

• Diploma in mechanical or electrical engineering with 3–5 years of manufacturing experience.
• Experience in assembly, automation, tooling and fixtures designs.
• Experience in project management and validation.
• Working knowledge of cGMP manufacturing settings.
• Knowledge of FDA regulations and ISO 13485/14971 is an added advantage.

Responsibilities

• Lead process engineering team to support the value stream and meet objectives.
• Drive automation projects to upgrade equipment and improve productivity.
• Lead validation activities and ensure schedule compliance.
• Manage equipment maintenance, risk assessment, and deployment of resources.
• Collaborate with cross-functional teams to achieve equipment effectiveness and OEE.

Education

Diploma in mechanical/electrical engineering

Tools

Fixtures design

Automation tooling

Assembly process tooling

Job description

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

Work Shift

DAY

Work Schedule

Job Functions

• 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 Diploma in mechanical/electrical with 3 to 5 years experience in manufacturing process environment. 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.

To see more on our culture, go to www.merit.com/careers.