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Course Criteria
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3.00 Credits
3 credits This course provides coverage of the characteristics, fundamentals, and manufacturing properties of materials, including metal alloys, polymers, ceramics, and composites. The metal-casting processes and the shaping and forming processes are also covered along with the machines needed for manufacturing. 47 contact hours.
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3.00 Credits
3 credits This course provides an introduction to the basic principles, and theories of lean manufacturing. Lean manufacturing involves identifying and eliminating non-value-adding activities in design, production, and supply chain management. The course introduces the concepts of Juran, Demming, Taylor, Ford, Shingo, and Ohno. The coverage also includes topics related to cost reduction, work-free manufacturing, continuous flow, Kaizen, the 5S's, value stream mapping, modular manufacturing, and overall equipment effectiveness (OEE). 47 contact hours.
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3.00 Credits
3 credits This course begins with an exploration of teams and how they work. Manufacturing teams create the opportunity to mix complementary technical work skills to improve the production process. The coverage includes the principles and tools used by self-directed teams in identifying and solving problems in the workforce. 47 contact hours.
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2.00 Credits
2 credits This course provides an introduction to telecommunications and network cabling concepts and includes hands-on projects involving the standards and codes necessary for cable installation for copper and fiber optics. The course also covers cable types and topologies, designing and installing telecommunications rooms, and the use of test instruments including network analyzers. 32 contact hours.
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3.00 Credits
3 credits This course focuses on the theories and principles of occupational safety and health in a practical and useful real world job related setting. The major topics include the Occupational Safety and Health Administration (OSHA) compliance, safety standards, code enforcement, ergonomic hazards, mechanical hazards, falling, lifting, electrical hazards, fire hazards, industrial hygiene, radiation, noise, emergencies, and environmental safety. 47 contact hours.
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3.00 Credits
3 credits Prerequisite: REA 0001. This course provides the students with an in-depth understanding of the principles and techniques of identifying, evaluating, and controlling risks associated with the development and production of medical devices. This course will cover risk management planning, risk analysis process, and risk management reporting. Topics will include the relationship between regulatory requirements and risk management, tools for hazard identification, methods for the mitigation of risks, and approaches for analyzing risk verses benefit. 47 contact hours.
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3.00 Credits
3 credits This course will cover the change control activities and procedures that apply to the design of systems, the components within those systems, labeling and packaging, device manufacturing processes, production equipment, and manufacturing materials. Additional topics will include all associated documentation such as the quality system procedures, standard operating procedures, the quality acceptance procedures and data forms, and product-specific documentation. 47 contact hours.
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3.00 Credits
3 credits Prerequisite: REA 0001. This course will provide an understanding of the processes and procedures using the Food and Drug Administration (FDA) regulation and compliance for the designing and manufacturing of medical devices. Topics include the design process, design tools and management, product and process development, documentation, verification and validation, post market surveillance, and corrective and preventative actions. 47 contact hours.
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3.00 Credits
3 credits This course presents the principles and techniques for assessing the adequacy of a quality system for a medical device manufacturer. Coverage includes evaluating the quality system as it conforms to FDA regulatory requirements, standards, review of standard audit terms, audit types, audit concepts, and methods for planning, conducting, and reporting audits. 47 contact hours.
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3.00 Credits
3 credits This course provides an introduction to the basic principles and theories of Six Sigma as used in the continual improvement process. The course examines the tools most common to six sigma projects and how and when to use them. Course coverage focuses on measurement methods, data collection, data integrity, and graphical methods of presenting findings. 47 contact hours.
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