This course provides the student with a set of skills to improve products and processes already in manufacturing as well as to develop products and processes in the development stages. The definition of DOE promoted is “a tool to assist in the process of understanding a system.” There will be discussion of how DOE fits into the overall product lifecycle and where it applies in the area of testing. Tools covered include full and fractional factorials, central composite, Box-Behnken, Taguchi, Evolutionary Operation and the method of steepest ascent. Theoretical statistics understanding is assumed prior the course. A standard, simple process will be presented which allows for improved communication and user confidence in using the tool set. The primary objective is to assist the student with implementing the skills learned during the course. This is an application-orientated course that includes case studies, team projects, student presentations and reports, guest lecturers and use of computational software. A quick statistical overview will be provided in the class as a refresher, but is not intended to cover the subjects in depth to students new to the subject. It is recommended students review all of the topics prior to starting the class.
Prerequisite: ETLS 506 Statistical Methods for Manufacturing Quality
This course teaches fundamentals of anatomy and physiology for nerves, muscle, heart, blood vessels, gastrointestinal system, urinary tract, liver and hormones. A broad range of disease states and medical devices are introduced to help students better relate to the anatomic and physiologic information presented. Class experience also includes guest speakers, one site visit at a local hospital and student presentations about devices and medical conditions.
Note: Credit will not be given for both ETLS 720 and ETLS 730 Cardiovascular Anatomy, Physiology and Medical Devices.
This course teaches the student about submissions for regulatory approval of medical devices. Topics include: medical device law, custom and research devices, significant and non-significant risk devices, FDA investigational device exemption, 510(k) substantial equivalence determination, pre-market approval, PMA supplements, third party review, combination devices, European economic area CE mark, international harmonization, MDR, device tracking, post market surveillance, annual post approval reporting. Depending upon the degree of class interest medical device submissions in Canada, Australia, and Japan may be covered.
This class will focus on the quality system requirements, from a regulatory viewpoint, for medical device manufacturers. The majority of the class time will be spent reviewing the FDA Quality System Regulation as well as ISO 13485 in relation to the ISO 9000 Series requirements. There will be general discussion on the U.S. and European submission process, especially in context of changes related to the quality systems that have been implemented. A few classes will focus on FDA inspections, and the ramifications of non-conformance. Classroom methodology will be lectures with substantial student interaction encouraged. Students will be encouraged to share their experiences from their own companies regarding the subjects being discussed. Some portions of several of the classes will be presented by students, sharing what they have learned from small group interaction during class time.
In this introductory course we will cover a broad spectrum of topic related to Biomedical Engineering. The goal of the course is to give the student a more comprehensive understanding of many of the topics related to Biomedical Engineering and begin to see how they must all fit together in a biomedical device. We will also review and discuss a number of real world devices and the issues involved in their design.
This course teaches clinical study design, research hypotheses, statistical considerations, clinical study planning and execution. Students are trained to apply this information to include clinical studies that encompass a wide variety of clinical objectives: prototype evaluation, pivotal studies, FDA approval requirements, marketing claims, customer acceptance, reimbursement, etc. Other topics include data form design, databases, applicable U.S. and International Regulations and selected topics of interest.
Lectures and instructional materials will emphasize the anatomy and physiology of the heart and blood vessels. Topics in general, nerve and muscle physiology will also be presented, since they are important in understanding how the heart and cardiovascular systems functions. Many cardiovascular diseases and contemporary cardiovascular devices will be covered during lectures and in student presentations. Guest speakers and a trip to a local Cardiac Catheterization Laboratory will complement the instruction materials.
Note: Credit will not be given for both ETLS 720 Anatomy and Physiology for Medical Devices and ETLS 730.
This course gives an introduction to the submission approval process, validation, manufacturing and quality requirements for combination products, drugs and biologics. Course topics will include a historic overview, the process to determine which FDA Center controls the regulatory process, applicable regulations and post-market approval practices for these products. Students will learn how the regulations and practices at CDER and CBER differ from CDRH. They will also learn how the FDA designated controlling center will shape the submission clearance/approval process, manufacturing control and post-market requirements for a combination product.
The course will provide an overview of the international medical device regulation including EU nations, Japan, Canada, Australia, Latin America, and other emerging markets. It will include case studies of the current international regulatory climate to help students develop practical applications and interpretations regarding the enforcement of these regulations.
As energy is one of the most important issues of this century, this course will provide the basic understanding of various Renewable and Classical electric energy generation techniques. It will cover, among others, Thermal, Hydro, Nuclear, Solar and Wind based power generation. It will also cover certain basic aspects of power storage and delivery. This course will help students in evaluation and analysis of various energy systems in the context of Technology, Economics and sustainability.
This course assists the student in developing a framework for understanding the technological environment and the process of technological change and in developing technological and strategic foresight.
Topics will include:
An introduction to the key elements of control systems employed in manufacturing with examples from both batch and continuous-process applications. First, the fundamental theory of operation for closed loop (binary and analog) control systems is developed. Students will explore using PLCs to implement modern systems and become familiar with a PLC programming language. Second, the theory of operation and performance limits of sensors and actuators used in the industrial environment is explored. Some sensors to be considered measure position, speed, temperature, flowrate, level, and force. Some actuators to be considered include pumps, hydraulic and pneumatic cylinders, heaters, valves, stepping motors, and AC and DC motors. Future trends in control systems targeted for the manufacturing plant will be presented. Students will demonstrate their ability to automate a manufacturing cell and quantify the cost impact of the project on the manufacturing example chosen in a term paper.
Prerequisite: Instructor's permission for MS and Certificate
This course introduces the student to theory and application of engineering materials. While particular emphasis is placed on traditional structural materials, emerging materials technology is also discussed. Topics explore the physical and mechanical properties of metals, polymers, ceramics, and composite materials. Useful applications and limitations of those materials are presented, and means of modifying their properties are discussed at length. Guest speakers and industrial tours supplement traditional learning by exposing the student to practical materials application, processing and evaluation.
This course covers the creation of tooling for thermoplastic injection molding, die casting, blow molding, and other related net shape processes. In-depth coverage is given to mold design and process parameters. Part design issues related to these processes are investigated including material selection, part geometry, and cost estimating. Computer tools applicable to net shape manufacturing are also discussed including CAD, flow analysis, rapid prototyping systems, and expert systems.
Prerequisite: ETLS 502 Manufacturing Processes
The field of Micro-Electro-Mechanical Systems (MEMS) refers to the design and manufacture of micron-scale devices which can ultimately be used to create both sensors and actuators that promise to be very small, very lightweight, very inexpensive, and very precise. By leveraging the mature state of semiconductor fabrication techniques within the integrated circuit industry, MEMS devices are beginning to emerge in the automotive, medical, aerospace, telecommunication, and biotechnology industries. This course will investigate the entire process of developing a micro-sensor idea into a product. Along the way, topics of discussion will include picking an appropriate application of the MEMS technology, designing a MEMS device, MEMS fabrication and packaging techniques, the challenging aspects of characterizing MEMS devices, and the unique physical environment that exists at the micron scale. Other discussions will address the existing MEMS market, the future of MEMS and the difficulties associated with establishing a successful MEMS business. The course will be taught through real world examples of existing MEMS implementations, drawing on both the successes and failures of past efforts to paint a realistic view of this exciting yet challenging new technology.
Prerequisite: ETLS 771 Materials Engineering
This course provides an introduction to mechatronic systems (i.e., intelligent electromechanical systems) that is useful to individuals managing the design or manufacture of such devices or as the foundation for further study in mechatronic design.
This course focuses on describing: what polymers are; how they are manufactured; why they behave the way they do; and how they are fabricated into structural objects-parts, fibers, films; how they can be compounded into alloys, reinforced composite structures, flexibilized toughened structures; how they are increasingly being used in functionally active roles-photopolymers as imaging elements in the printing and electronics industries, polymer membranes in separation processes, polymer fiber optics, photonic elements and optical discs. The presentation method is highly descriptive with frequent reference to commercial examples and attempts to avoid, to the degree compatible with qualitative understanding, detailed excursions into underlying chemistry and rigorous mathematical physics.
Prerequisite: ETLS 771 Materials Engineering
Provides a comprehensive overview of ceramic materials and processing with special emphasis on newer so-called advanced ceramics. Examples include aerospace materials, bioceramics, engine components, optical fibers, multilayer electronic substrates, and oxide superconductors. The goal is to familiarize students with the broad array of ceramic materials, their uses, advantages, and disadvantages. Important design and manufacturing issues will be discussed. Specific topics will include glass processing and properties, ceramic powder processing, advanced processing, composites, mechanical properties, electrical ceramics, traditional and advanced applications, and related background materials such as crystal structures and phase diagrams.
Prerequisite: ETLS 771 Materials Engineering
This course teaches techniques which are needed to apply the finite element method to a wide array of engineering problems. The course will utilize the ANSYS FEA software for addressing problems in structural and thermal mechanics. The sole course assignment will be a major design project which will be based on real-world engineering application. The outcome of the design project will be a report of publishable quality.
An introductory graduate course covering various computer based tools such as EXCEL, VISIO, VBA, and ARENA to understand and improve business operating systems; manufacturing, service or a combination. Major emphasis will be on using these tools to document and analyze process design and/or improvement problems from students’ work environments.
Prerequisite: Basic knowledge of statistics and Excel
A work oriented/internship opportunity to experience U.S. manufacturing techniques in a real-world setting for students who seek on-the-job manufacturing experience. May be taken three times for credit.
This course covers current software and methodologies used to model and simulate manufacturing processes, logistics and industrial systems. After studying a leading simulation tool in detail, a term project requires each student to evaluate the potential role of computer simulation in his/her work environment.
Prerequisite: ETLS 501 Manufacturing Systems and ETLS 778 Process Design & Improvement - Computer Based Tools
Many engineering systems are inherently dynamic in nature. Characterizing and designing such systems requires mathematical modeling, simulation, and visualization using modern software such as MATLAB(TM), SIMULINK(TM), and SolidWorks(TM), possibly with add-on modules. Lectures focus on the detailed applied mathematical modeling of a variety of systems from different energy domains with a bias towards mechanical systems such as mechanical translational, mechanical rotational, hydraulic, thermal, among others. The basics of “bond graph theory,” a unifying theory based on a chemical bonding analogy, is discussed as well. The integrated laboratory has 3 components to it: (1) software training (as necessary) in MATLAB(TM), SIMULINK(TM), and SolidWorks(TM), including “add-ons,” and “toolboxes” as needed, (2) developing dynamic models using MATLABTM and SIMULINKTM, (3) creating CAD models of systems, and (4) integrating the dynamics models with the visualization to create computer animations of the resulting motions of the mechanical systems. Students also work on a team-based dynamic simulation and visualization of mechanical systems project. This course currently serves as one of several “Mechanical Systems and Control” concentration courses for the newer MSME program.
Manufacturing and leadership topics will be presented. (This course may be repeated for credit.)