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A global leader in medical devices is seeking an Automation Engineer in Penang, Malaysia. In this role, you will optimize automated manufacturing equipment, lead troubleshooting, and support new installations while ensuring compliance with medical standards. Candidates should have a Bachelor’s degree in a relevant engineering field and 5-8 years of experience in automation systems. Join an innovative team that values growth, safety, and compliance while working in a fast-paced environment.
You maintain and optimize automated manufacturing equipment to ensure peak performance and compliance with medical device standards.
You lead troubleshooting and root cause analysis for equipment-related issues to minimize downtime.
You support installation, setup, and qualification of new automated equipment and systems.
You perform on-site equipment buyoff and acceptance testing with vendors.
You participate in equipment design discussions to influence manufacturability and reliability.
You prepare, edit, and execute IQ (Installation Qualification) and OQ (Operational Qualification) protocols for new equipment.
You draft new IQ/OQ documentation and ensure compliance with regulatory standards.
You collaborate on automation, IoT integration, and SCADA system projects (e.g., Ignition) to enable smart manufacturing and real-time equipment monitoring.
You drive continuous improvement initiatives to enhance productivity, yield, and cost efficiency.
You ensure adherence to safety, environmental, and regulatory requirements (ISO 13485, FDA).
You work closely with cross-functional teams to implement automation solutions and best practices.
You have strong knowledge of automation systems, robotics, and PLC programming/software (Siemens, Allen-Bradley, or similar).
You have hands‑on experience with pneumatic systems and electrical troubleshooting.
You have understanding of IoT technologies for equipment connectivity and data analytics.
You have familiarity with SCADA systems (e.g., Ignition) for equipment monitoring and control.
You have Medical Manufacturing Knowledge: Understanding of GMP, ISO 13485, and FDA requirements.
You have ability to analyze complex equipment issues and implement effective solutions quickly.
You have continuous Improvement Mindset: Familiarity with Lean, TPM (Total Productive Maintenance), or Six Sigma principles.
You have excellent communication and teamwork skills to work across departments.
You can thrive in a fast‑paced, highly regulated environment with evolving technologies.
You can expect occasional travel may be required for new project transfers from HQ, equipment buyoff, vendor support, or training (domestic and international).
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A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in‑house learning programs and/or qualified tuition reimbursement.
An exciting and innovative, industry‑leading organization committed to our employees, customers, and the communities we serve.
50-75%
Typically requires a Bachelor’s degree in Mechanical, Electrical, Mechatronics, or related engineering field, and a minimum of 5 – 8 years of related experience