Process Engineer (Medical devices)

JOB OBJECTIVE

This role drives process and automation engineering excellence to support the plant's operational goals. Key responsibilities include managing automation projects, ensuring process validation, troubleshooting equipment, and providing technical leadership for value stream manufacturing operations.

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 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.

For interested applicants, kindly send your resume in Word/PDF format to include the following in your resume including:

1. Current Salary
2. Expected Salary
3. Availability
4. Reason for leaving

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