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Staff Automation Engineer (Medical Device)

Staff Automation Engineer (Medical Device)

DexcomGeorge Town, Malaysia
12 jam yang lalu
Penerangan pekerjaan

Staff Automation Engineer (Medical Device)

You will be part of the Global Engineering team within Operations, tasked with end-to-end technical oversight of our manufacturing technologies spanning our suppliers, contract manufactures and automation houses. Including providing technical support for on-market production at our manufacturing sites. You will bring your expertise and passion for plastic injection molding automation and validation, working closely in cross-functional teams to integrate cutting-edge technology into our manufacturing processes. You will ensure high efficiency, precision, and quality in our operations. You will play a pivotal role in ensuring robust new product introduction, capacity expansions, and sustained on-market performance. This crucial role supports Dexcom's thrilling growth trajectory in delivering essential, life-changing products to our valued customers. As part of this dynamic and highly effective team, you will collaborate closely across multiple functions, gaining broad exposure to our entire product life cycle. Where you come in : You will lead and collaborate with internal and external cross-functional teams in the development of product assembly equipment, system architecture, robotics concepts, and tooling. You will initiate and conduct feasibility studies, testing on new and modified designs, and analyze mechanical systems and equipment. You will develop test plans, equipment requirements, protocols, and reports to ensure designs meet product specifications, regulatory requirements, and standards for new equipment and processes, including IQ / OQ / PQ protocols. You will review and approve equipment acceptance testing (FAT / SAT) and validation protocols (IQ / OQ / PQ) and reports for new or modified production equipment at contract manufacturing partners. Assist in protocol execution as needed. You will plan, design, develop, and execute equipment improvement projects, ensuring comprehensive documentation and timely communication with leadership and cross-functional teams. Lead root cause investigation activities related to equipment and processes. You will review and analyze daily contract manufacturing production data, implementing strategies to enhance output and efficiency of equipment performance. What makes you successful : You have extensive experience with robotics used in molding processes, such as pick-and-place robots, demonstrating proficiency in their programming, integration, and optimization within manufacturing systems. You are also highly skilled in troubleshooting and maintaining molding machines and automation equipment, ensuring continuous, efficient, and high-quality production. You possess exceptional problem-solving and analytical skills, with the ability to interpret complex data and make informed decisions. You can work effectively in a team environment, collaborating with cross-functional partners in manufacturing, R&D, supply chain, and quality assurance to achieve common goals. You effectively communicate with internal teams and external partners. This includes conveying technical concepts clearly, providing timely updates, and fostering collaborative relationships to ensure alignment and successful project outcomes. You must be able and capable to travel to our automation vendors and contract manufacturing partners to investigate production or quality related issues and troubleshoot equipment. You collaborate with R&D on design for manufacturing considerations for new product development and work with automation houses to provide oversight into equipment design for high-scale manufacturing. You support the development of productive partnerships for stable on-market performance and drive continuous improvement efforts. You drive innovation in approach, processes, and methodologies while ensuring adherence to company, customer, and industry requirements and specifications. You lead the identification and implementation of technology and process solutions to enhance performance and achieve both short-term and long-term objectives. Bachelor’s degree in mechanical engineering or related field. Possesses extensive hands-on experience with high-volume automation assembly and test machines for molded parts, including the development of proof of concepts to evaluate and optimize automation assembly methods. Demonstrates expertise in maintaining and developing fixtures and equipment, designing and developing robotics, and troubleshooting for high-volume, Class II medical devices. Expert in statistical process control (SPC) and proficient in using software tools such as Minitab or JMP for data analysis, process troubleshooting and optimization. Proficiency in SolidWorks, dimensional tolerancing and GD&T Standards. Demonstrated success in driving continuous improvement initiatives using LEAN, KAIZEN, and Six Sigma methodologies to significantly enhance equipment efficiency, reduce operational costs, and elevate product quality standards. What you’ll get : A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. 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. Travel Required : 15-25% Experience and Education Requirements : Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 8-12 years related experience or Master’s degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.

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