- Location
- Penang,MY, MY
- Workplace
- Onsite
- Type
- Full-time
- Department
- Engineering
- Experience
- 3+ years
- Source
- Eightfold
Description
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 Senior Equipment Engineer, you will:
- Maintain and optimize automated manufacturing equipment to ensure peak performance and compliance with medical device standards.
- Lead troubleshooting and root cause analysis for equipment-related issues to minimize downtime.
- Support 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.
- Drive continuous improvement initiatives to enhance productivity, yield, and cost efficiency.
- Ensure adherence to safety, environmental, and regulatory requirements (ISO 13485, FDA).
- Work closely with cross-functional teams to implement automation solutions and best practices.
What Makes You Successful:
- 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.
- Problem-Solving Skills: Ability to analyze complex equipment issues and implement effective solutions quickly.
- Continuous Improvement Mindset: Familiarity with Lean, TPM (Total Productive Maintenance), or Six Sigma principles.
- Collaboration: Excellent communication and teamwork skills to work across departments.
- Adaptability: Thrive in a fast-paced, highly regulated environment with evolving technologies.
Qualifications:
- Bachelor’s degree in Mechanical, Electrical, Mechatronics, or related engineering field.
- 3–5 years of experience in equipment engineering 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.
Additional Requirements:
- Travel: Occasional travel may be required for new project transfers from HQ, equipment buyoff, vendor support, or training (domestic and international).
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.