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. AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.