ETI 1030 REGULATORY ENVIRONMENT FOR MEDICAL DEVICES 3 credits

This course will provide an understanding of the basics of the Food and Drug Administration (FDA) regulation and compliance for medical devices including how the various activities within a medical device company are affected by the FDA regulations. Additional coverage will include the applicable laws and regulatins enforced by the FDA;  international standards and regulations; the regulations controlling medical device design and development; the medical device approval process; laboratory and clinical studies; the introduction to the Quality System Regulations (QSRs); and the FDA inspection process. 47 contact hours.

ETI 1110 INTRODUCTION TO QUALITY ASSURANCE 3 credits

This course defines the role of quality in an industrial environment. Topics include the use of quality management techniques and quality philosophies, process development, techniques used for evaluation, approaches used on continuous operations, methods used to control quality, and the International Organization for Standardization (ISO) series of standards. The responsibility of quality assurance during the engineering, manufacturing, and marketing of a product is also covered. 47 contact hours.

ETI 1420 MANUFACTURING PROCESSES AND MATERIALS I 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.

ETI 1622 CONCEPTS OF LEAN AND SIX-SIGMA 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.

ETI 1628 DEVELOPING AND COACHING SELF-DIRECTED WORK TEAMS 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.

ETI 1688C NETWORK CABLING FUNDAMENTALS 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.

ETI 1701 INDUSTRIAL SAFETY 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.

ETI 2031 RISK MANAGMENT AND ASSESSMENT FOR MEDICAL DEVICES 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.

ETI 2032 CHANGE CONTROL AND DOCUMENTATION 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.

ETI 2041 MEDICAL DEVICE DESIGN AND MANUFACTURING 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.

ETI 2171 QUALITY AUDITING FOR MEDICAL DEVICES 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.

ETI 2610 PRINCIPLES OF SIX SIGMA 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.

ETI 2619 SIX SIGMA PROJECT MANAGEMENT 3 credits

Prerequisite: ETI 2624. This course provides the concepts and methods for implementing Six Sigma project management utilizing Six Sigma methodologies. The course will cover the aspects of developing projects, managing risk, understanding customers’ needs and requirements, estimating costs, developing schedules, integrating cost and schedule controls, and evaluating projects. This course will also utilize a variety of project management tools and performance measures including the model of define, measure, analyze, improve, and control (DMAIC). 47 contact hours.

ETI 2623 TOOLS FOR LEAN MANUFACTURING 3 credits

This course provides an overview of the Lean Manufacturing concepts with a working knowledge of the tools required to implement and maintain a Lean Manufacturing facility. Course coverage includes mistake proofing, the 5S’s for operators, quick changeover, Overall Equipment Effectiveness (OEE), cellular manufacturing, and the kanban system. 47 contact hours.

ETI 2624 SIX SIGMA BLACK BELT CONCEPTS 3 credits

This course addresses the roles and responsibilities required for a Six Sigma Black Belt candidate. This course also covers the advanced six sigma tools beyond those tools using the model of define, measure, analyze, improve, and control (DMAIC). The student will be required to exhibit a mastery of the concepts and tools through projects, exercises and case studies as they apply to both manufacturing and service industries. 47 contact hours.

ETI 2626 SIX SIGMA CAPSTONE PROJECT 3 credits

The student will develop a suitable Six Sigma project by utilizing the Six Sigma methodologies. A specific problem or set of problems will be identified and solved using the Six Sigma methods of improvement to deploy on the project. This course will emphasize the different phases of the project to include design, verification, and implementation. The completion of this project requires a written report and a formal presentation of the Six Sigma process. 47 contact hours.

ETI 2670 TECHNICAL ECONOMIC ANALYSIS 3 credits

This course defines the economic evaluation of engineering alternatives and analysis of cost allocation in technical operations. Topics include the time value of money and the economic impact of risk, inflation, depreciation, and capital budgeting with applications related to those areas. 47 contact hours.

ETI 3116 QUALITY MANAGEMENT 3 credits

Prerequisite: MAN 3504 or permission of the Dean. This course helps students to understand how quality products, processes, and services require integration across complex systems of customers, suppliers, technology, and people. This course covers the fundamental methods used to define quality, as well as how to connect this definition to measures that can be analyzed to drive quality improvements and control performance. This course helps students understand, integrate, and apply quality management (Six Sigma) concepts and techniques to better plan, organize, lead, and control quality improvement projects that can help organizations to better focus on achieving their strategic goals and objectives. 47 contact hours.

ETI 3413 MANUFACTURING SYSTEMS AND PROCESSES 3 credits

Prerequisite: MAN 3504 or permission of the instructor. This course presents the advanced machining processes, equipment, and systems used in competitive manufacturing environments. Characteristics of surface technology, micro-electronic device fabrication, quality assurance, human factors engineering, product liability, automation, and techniques of modern integrated manufacturing systems are presented. 47 contact hours.

ETI 3647 SUPPLY CHAIN MANAGEMENT 3 credits

Prerequisite: MAN 3504 and admission to the Technology Management or International Business BAS program. This course presents the basic concepts, principles, techniques of supply chain management. Emphasis will be on the student developing a solid enterprise wide view while centering them in the real themes, demands, and opportunities of an evolving and dynamic business workplace. This course will incorporate basic supply chain management, inventory management, and logistic management as they relate to the core aspects of the management practice. 47 contact hours.

ETI 4448 APPLIED PROJECT MANAGEMENT 3 credits

Prerequisite: Admission to the Technology Management or International Business BAS program. The student should have a working knowledge of basic project management concepts and Project Management software tools. This course provides students with an understanding of the concepts of project management (PM) and its application in the information technology environment. Students will gain an understanding of the fundamentals of the project management framework and understand how to apply the nine project management areas — integration, scope, time, cost, quality, human resources, communications, risk and procurement management. The project management processes of initiating; planning, executing, controlling and closing used in information technology projects will be covered. Techniques suitable for management of large and small projects in business environments will be discussed. 47 contact hours.

ETI 4621 LEAN ESSENTIALS 3 credits

Prerequisite: MAN 3504 or PLA 1763 or permission of the Dean. This course presents the basic principles, techniques, and benefits of lean manufacturing for a world-class manufacturing environment. Lean manufacturing involves identifying and eliminating non-value-adding activities in design, production, supply chain management, and customer relations as applicable to manufacturing and service organizations. 47 contact hours.