Process Engineer (Medical devices)

RRecruiter; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

RRecruiter is seeking aSenior Process Engineer to lead the Process Engineering team in Singapore. You will drive automation initiatives, oversee equipment maintenance, and champion process validation to maximize uptime and product quality in a regulated environment.

Ideal candidates bring extensive hands-on automation experience within medical devices or pharma, with strong skills in robotics, fixture design, and regulatory familiarity (FDA/EU MDR/ISO standards).

Qualifications

• Bachelor’s degree in Mechanical/ Electrical Engineering or Materials Science.
• 5–10 years hands-on automation and automated assembly experience in medical device/pharma.
• Experience in automation systems, robotics, tooling and fixture design/development.
• Led automation projects from concept to implementation including qualification and validation.
• Working knowledge of cGMP manufacturing environments.
• Strong knowledge of assembly process optimization, manufacturing automation, equipment reliability and process capability.
• Familiarity with FDA regulations, EU MDR 2017/745, ISO 13485 and ISO 14971 is an advantage.

Responsibilities

• Lead the Process Engineering team to support production and value-stream objectives.
• Drive initiatives to maximize machine uptime, equipment reliability, process capability, yield, output, quality and OEE.
• Lead automation, equipment upgrade, and assembly process improvement projects.
• Oversee equipment maintenance, preventive maintenance, calibration, and risk assessment activities.
• Lead equipment/process validation and provide required engineering resources and support.
• Drive continuous improvement and productivity initiatives while minimizing production disruptions.
• Manage engineering resources, budgets, and capital expenditure (CAPEX).
• Collaborate with cross-functional teams, suppliers, subcontractors, other plants, and external parties to improve equipment and process effectiveness.
• Ensure compliance with quality, safety, environmental, and company policies through effective communication, training, and implementation.

Skills

Automation systems

Robotics

Fixture design

Process validation

cGMP knowledge

Assembly optimization

Equipment reliability

CAPEX management

Education

Bachelor’s degree in Engineering

Job description

Location: Yishun

Key Requirements

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Materials Science, or a related field.

• 5–10 years of hands‑on experience in automation and automated assembly, preferably in the medical device or pharmaceutical industry.

• Strong experience in automation systems, robotics, automated assembly, tooling, and fixture design/development.

• Proven ability to lead automation projects from concept to implementation, including equipment qualification and process validation.

• Working knowledge of cGMP manufacturing environments.

• Strong knowledge of assembly process optimization, manufacturing automation, equipment reliability, and process capability.

• Familiarity with U.S. FDA regulations, EU MDR 2017/745, ISO 13485, and ISO 14971 is an advantage.

Job Function

• Lead the Process Engineering team to provide effective support to production and value-stream objectives.

• Drive engineering initiatives to maximize machine uptime, equipment reliability, process capability, yield, output, quality, and OEE.

• Lead automation, equipment upgrade, and assembly process improvement projects.

• Oversee equipment maintenance, preventive maintenance, calibration, and risk assessment activities.

• Lead equipment/process validation and provide the required engineering resources and support.

• Drive continuous improvement and productivity initiatives while minimizing production disruptions.

• Manage engineering resources, budgets, and capital expenditure (CAPEX).

• Collaborate with cross-functional teams, suppliers, subcontractors, other plants, and relevant external parties to improve equipment and process effectiveness.

• Ensure compliance with quality, safety, environmental, and company policies through effective communication, training, and implementation.

Interaction

• Internal: Communicate and collaborate effectively with associates at all levels and cross-functional teams.

  External: Coordinate with other Merit Medical plants, corporate/regional/business teams, suppliers, subcontractors, and government agencies as required.