ETLS 701 Design of Experiments
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
ETLS 720 Anatomy and Physiology for Medical Devices
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.
ETLS 721 Medical Device Regulatory Submissions
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.
ETLS 722 Medical Device Quality Systems
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.
ETLS 724 Medical Device Clinical Studies
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.
ETLS 730 Cardiovascular Anatomy, Physiology and
Medical Devices
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.
ETLS 752 Technology Forecasting and Strategic Prospective
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:
- Techniques for describing, monitoring and understanding trends and
forces in the technological environment;
- An overview of the history of technological change and analysis of
the relationship between technological change and forces in the economic,
social, political and natural environments;
- Application of these concepts in the development and use of models for
anticipating and planning for future technological and strategic change.
ETLS 770 Automated Control of Manufacturing Processes
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
ETLS 771 Materials Engineering
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.
ETLS 772 Injection Molding, Die Casting, and Related Net
Shape Processes
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
ETLS 773 Principles of MEMS Product Development
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
ETLS 775 Polymers in 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
ETLS 776 Advanced Engineering Materials
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
ETLS 777 Finite Element Analysis
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.
ETLS 778 Process Design and Improvement - Computer Based
Tools
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
ETLS 783 Practical Study and Training in Manufacturing
(1 credit course)
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.
ETLS 785 Simulation of Logistics and Industrial Systems
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
ETLS 799 Selected Topics
Manufacturing and leadership topics will be presented. (This course may be repeated for
credit.)
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