Process Engineer

565 Merit Medical Singapore Pte. Ltd. F.K.A Argon Critical Care Systems Singapore Pte. Ltd.; Singapore; On-site; SGD 54,000 - 84,000; Full time

Job summary

Merit Medical Singapore Pte. Ltd. is seeking a Diploma-educated Process Engineer to lead the process engineering team in supporting the value stream and achieving production objectives.

The role focuses on maximizing machine uptime, driving automation initiatives, and improving yield and quality across the manufacturing line. The successful candidate will manage maintenance, validation, and TPM activities, work with cross-functional teams, and ensure compliance with cGMP and ISO standards in a

Qualifications

• Diploma in mechanical/electrical engineering with 3–5 years in manufacturing environment.
• Experience in medical device/manufacturing preferred.
• Familiarity with assembly process, automation, tooling & fixtures design.
• Experience in project management and validation.
• Working knowledge of cGMP manufacturing practices and FDA/ISO standards is advantageous.

Responsibilities

• Lead process engineering team to support the value stream and meet objectives.
• Ensure optimal machine uptime for production.
• Lead automation projects including equipment upgrades and productivity initiatives.
• Improve yield, output and quality through engineering initiatives.
• Plan and execute maintenance/upgrade activities with risk-based approach.
• Support TPM activities and process validation efforts.
• Coordinate with cross-functional teams to achieve equipment effectiveness and cost control.
• Manage capital expenditure and ensure compliance with quality and safety policies.

Skills

Process engineering

Team leadership

Automation

Project management

Quality systems knowledge

Education

Diploma in mechanical/electrical engineering

Tools

Automation tooling design

Fixtures design

Job description

Work Shift: DAY

Work Schedule: 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.

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.

Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 500 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.

UNDERSTAND. INNOVATE. DELIVER. Merit Medical is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy.