Staff Equipment Engineer

Meet the Team:

At Dexcom Malaysia, our Manufacturing Engineering team ensures that cutting-edge medical devices are produced with precision, reliability, and efficiency. We work in a highly regulated environment where quality and innovation go hand-in-hand to improve lives globally.

Where You Come In:

As a Staff Equipment Engineer and Subject Matter Expert (SME), you will:

• Lead and mentor a team of equipment engineers, providing technical guidance and fostering skill development.
• Act as the SME for equipment engineering, setting best practices and driving technical excellence in automation, IoT, and SCADA systems.
• Drive strategic initiatives for equipment reliability, automation, and smart manufacturing.
• Maintain and optimize automated manufacturing equipment to ensure peak performance and compliance with medical device standards.
• Lead troubleshooting and root cause analysis for complex equipment issues to minimize downtime.
• Oversee installation, setup, and qualification of new automated equipment and systems.
• Perform on-site equipment buyoff and acceptance testing with vendors.
• Participate in equipment design discussions to influence manufacturability and reliability.
• Prepare, edit, and execute IQ (Installation Qualification) and OQ (Operational Qualification) protocols for new equipment.
• Draft new IQ/OQ documentation and ensure compliance with regulatory standards.
• Collaborate on automation, IoT integration, and SCADA system projects (e.g., Ignition) to enable smart manufacturing and real-time equipment monitoring.
• Lead continuous improvement initiatives to enhance productivity, yield, and cost efficiency.
• Ensure adherence to safety, environmental, and regulatory requirements (ISO 13485, FDA).
• Act as a technical liaison with global teams and vendors for advanced equipment solutions.

What Makes You Successful:

• Leadership: Ability to lead projects, mentor junior engineers, and influence technical direction.
• Subject Matter Expertise: Deep knowledge in equipment engineering, automation, and smart manufacturing technologies.
• Technical Expertise:
• Strong knowledge of automation systems, robotics, and PLC programming/software (Siemens, Allen-Bradley, or similar).
• Hands-on experience with pneumatic systems and electrical troubleshooting.
• Understanding of IoT technologies for equipment connectivity and data analytics.
• Familiarity with SCADA systems (e.g., Ignition) for equipment monitoring and control.
• Medical Manufacturing Knowledge: Understanding of GMP, ISO 13485, and FDA requirements.
• Continuous Improvement Mindset: Familiarity with Lean, TPM (Total Productive Maintenance), and Six Sigma principles.
• Strategic Thinking: Ability to plan and execute long-term equipment improvement strategies.

Qualifications:

• Bachelor’s degree in Mechanical, Electrical, Mechatronics, or related engineering field.
• 5+ years of experience in equipment engineering with leadership and SME responsibilities within medical device or high-tech manufacturing.
• Hands-on experience with automated equipment, preventive maintenance, and troubleshooting.
• Experience in PLC programming/software, pneumatic systems, electrical circuits, IoT integration, SCADA systems (Ignition preferred), TPM, and IQ/OQ documentation and execution is highly preferred.

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