ETLS 500-599 Introductory and Overview Courses:
Course Descriptions

ETLS 501 Production and Operations Systems

A comprehensive review of modern production methods and systems for production and service industries. Topics include location and facility layout, job design and measurement, group technology, push/pull systems, process planning, forecasting, production and capacity planning, scheduling and manufacturing systems. The course also provides a brief review of FMC, FMS, CNC, DNC and computer-integrated manufacturing.

ETLS 502 Manufacturing Processes

An overview of manufacturing processes with the objective of establishing the processes most appropriate to the characteristics and production requirements of the product. Metallurgy is briefly reviewed as a basis for material processing. Many conventional methods of fabrication are covered. Design for manufacturing and assembly techniques will be studied along with assembly methods and flow. Clean rooms and electronic assembly are also covered. Students unfamiliar with manufacturing processes will need to do independent study to determine all of the processes available.

ETLS 504 Excellence in Operations

An advanced course in concepts essential to achieving excellence in operations. The course covers the development and implementation of a coherent manufacturing strategy consistent with business and corporate strategies; importance of global competitiveness; and structuring of the production process based on the manufacturing mission. The human interaction involved in current quality issues, Just In Time (JIT), Total Productive Maintenance (TPM), set-up time reduction, simultaneous engineering, lean manufacturing and contemporary logistics systems, employee involvement and teamwork are key concepts of this course.

ETLS 505 Managerial Accounting and Performance Management

This course integrates the concepts of financial accounting, cost accounting and performance measurement as they are applied in the enterprise. The course emphasizes the concepts, terms, and techniques for using accounting and measurement information in planning, decision-making, and performance evaluation. Topics include analysis of financial statements, manufacturing and operations costs, fixed and variable costs, capital investment analysis, pricing, job and process cost systems, budgeting, responsibility accounting, cost allocation, and activity-based costing. Also covered are operational measures emphasizing physical units, process analysis, productivity measurement, and other non-accounting operational key indicator measurements. Consideration is also given to the influence of such concepts as Total Quality Management (TQM), Just In Time (JIT), Benchmarking, the Balanced Scorecard, Reengineering, Six Sigma, and Baldrige Awards as they relate to accounting and performance measurements.

ETLS 506 Statistical Methods for Manufacturing Quality

An introduction to the basic philosophy of the statistical tools used to assure manufacturing quality. Tools to include: hypothesis testing, regression analysis, analysis of variance, process capability, control charts (SPC), and six sigma. Students will conduct and report an industry-based statistical application project.

ETLS 507 Introduction to Systems Engineering

This course considers the engineering of both natural and human-made systems as well as the analysis of those systems. The principal focus of the course will be relating to the initial creation an development of complex systems. In general, this will relate to the development of systems which cross multiple domains of expertise. The course will convey to the students the essential elements of systems engineering; including systems thinking, systems analysis, system architecture, the decomposition and re-composition of systems design, risk management, reliability, maintainability and availability, and the coherent structure of a systems view. This course will be ideal for any student seeking to expand their current project management skills to enable them to effectively execute large and complex programs, or simply to manage their current projects with a systems view perspective.

ETLS 508 Systems Design

This course provides the student with an overview of the processes involved in the analysis, design, and implementation of systems. This is a hands-on course and is targeted at graduate students. Topics to be covered include the development life cycle, feasibility studies, requirements analysis, systems analysis, and systems design. Systems analysis and design methods covered in this course include both a software and hardware approach.

Module 1 - Systems Analysis Fundamentals
Module 2 - Practical Systems Analysis
Module 3 - Practical Systems Design
Module 4 - Introduction to Object Orientation

During the semester, the student will be involved in the analysis and design of a complex system. This project is an important part of the course because it provides the opportunity to confront real-life situations and problems during the systems analysis and design process. It is, therefore, essential for the student to be actively involved in this project. Students are required to learn the necessary technology to contribute to the project in a meaningful way.

Prerequisite: ETLS 507 Introduction to Systems Design

ETLS 509 Verification and Validation: Integration and Beyond

This graduate course considers two closely related but distinct concepts in systems engineering, verification and validation. Verification is “The process of evaluating a system or component to determine whether the products of a given development phase satisfy the conditions imposed at the start of that phase.” (IEEE Standard Glossary of Software Engineering Terminology, Standard 610.12-1990.) Validation is the act of assessing the requirements, design, and development of a product to ensure that it will meet the user’s requirements, operational needs, and expectations at the time of delivery. These activities occur throughout the systems engineering cycle, not simply at the end. Systems engineering verification and validation practices will be studied and applied in appropriate situations.

Prerequisites: ETLS 507 - Introduction to Systems Design, ETLS 508 - Systems Design

ETLS 520 Design and Manufacturing in the Medical Device Industry

This course is designed to provide an introductory overview of the medical device industry, and it’s unique design and manufacturing challenges. The course first examines the industry itself, reviewing basic industry statistics, current trends, and the many types of products that make up the medical device industry. It then helps students understand the fundamental systems that are used in the design, development, and manufacture of medical devices and how these relate to regulations governing the development and manufacturing processes. Finally the course explores in detail some of the unique aspects of manufacturing a medical product such as special material and process selection considerations, clean rooms, sterile packaging, sterilization processes, clinical testing, lot traceability and manufacturing control.

ETLS 530 Fundamentals of Engineering for Educators

This is a one-semester survey of engineering topics. Topics will span the role of engineering in society, statics, material strength, engineering design, machine design, manufacturing, electronics, computer programming, sensors/controls, thermodynamics and fluids. The course will have weekly lab sessions which will allow students to apply what they are learning from lectures in a hands-on setting. Emphasis will be placed on how the material is used by practitioners. Numerous examples will be given of how this material can be presented in a way that meets Minnesota education standards. Each topic unit will include a component dedicated to the historic and current relevance of the concepts and skills presented. Whenever appropriate, and feasible, guest lectures and field trips will be arranged. The goal of this course is to provide teachers with a short, hands-on introduction to a variety of engineering.

ETLS 541 Clinical Evidence

Clinical evidence is the human use experience reported in the literature obtained from clinical studies, published literature and/or post-market experience reports. Clinical evidence supports the safety and effectiveness of new or currently marketed medical devices. Regulatory professionals are often relied upon to coordinate obtaining this experience and summarizing it for U.S. and worldwide regulatory requirements. Students will learn about the various types of clinical evidence, how clinical evidence is obtained and used and the broad requirements for clinical evidence.

1.0 Credit
ETLS 542 FDA Submissions/Presentations
The course presents best practices for planning and preparing FDA submissions and oral presentations, including the technical aspects of developing regulatory materials. Preparation involves: (1) defining the objectives for such materials, (2) recognizing limitations and constraints of available information and the intended audience, (3) material preparation, (4) evaluating if objectives will be met, (5) evaluating if audience member limitations and constraints will be addressed, (6) self-review of materials in preparation and (7) soliciting and incorporating feedback from others. Students will have an opportunity to develop these skills by preparing a submission or oral presentation to address a simulated regulatory requirement. 

1.0 Credit 
ETLS 543 Pre-clinical Testing
Pre-clinical testing is summarized in many types of regulatory submissions, notifications, registrations, etc. for new and marketed medical devices. Regulatory professionals are relied upon to specify FDA (and international regulatory) expectations for preclinical testing. They coordinate obtaining these test results and summarize them for U.S. and worldwide requirements. This course will give an overview of the major pieces of pre-clinical testing required to develop design inputs, evaluate device design and validate that design inputs have been met. 

1.0 Credit
ETLS 544 Medical Device Reimbursement
Students will learn the basic fundamentals of reimbursement, coding, coverage and payment. Students will gain an understanding on how these concepts impact the regulatory process. They will learn how to apply these fundamentals to strategic thinking through real-world case studies and examination of current healthcare issues. 
1.0 Credit 
ETLS 545 Medical Device Risk Management
The risks involved in medical device development and use are explored. Risk mitigation activities associated with development of an actual medical device are presented and then experienced through their application for a hypothetical medical device. Class time is devoted to providing feedback for individual student projects about mitigating the development risks for a student chosen real or hypothetical medical device.
1.0 Credit
ETLS 546 - Medical Device Verification and Validation
The results of verification and validation activities are summarized in many types of FDA submissions, for new and marketed medical devices. Regulatory professionals are often relied upon to coordinate obtaining this information and summarizing it for U.S. and worldwide requirements. The course will focus on medical devices rather than pharmaceutical manufacturing. Lecture topics for this course include: Design Verification, Process Validation, Design Validation, Test Method Validation, Re-validation, Software Validation, Sterilization Validation, Equipment Validation, Inspection Method Validation. 
1.0 Credit

ETLS 550, 650, 850

Leveraging Leadership for a Lifetime I, II, III

This series of three one-credit courses is a requirement for a graduate student in the Master of Science in Technology Management program. The series, which wraps the entire program, aims to provide the student with an ongoing close look at oneself as a learner, a leader and the person in charge of his/her life-long plan. The series intends to answer the question, “How do I get the best possible results for my life goals in this graduate program?” It includes self-assessment in a number of differing arenas (see list below), providing a roadmap for learning actions throughout the graduate program. Key outcomes include: a more comprehensive self-understanding and awareness of values, learning and leading styles, personality characteristics and social/ethic responsibilities; a defined learning contract for the 3-5 year graduate program that will help shape a life-long learning plan; a defined leadership agenda that maximizes application of all graduate learning in the workplace and in life; and a portfolio demonstrating learning accomplishments throughout the program.

This series of courses are intentionally staged throughout the graduate process: I at the onset of the program, II at mid-point, and III at the finish. These provides a wrapping for a more intentional and deliberate focus on the learning process itself, stimulating innovation, courage and passion. In turn, this develops critical self-awareness and responsibility for learning while defining key leadership actions and applications. Throughout the series, methods to accomplish the objectives include written papers, group presentations, and feedback from others in the students’ personal/professional settings, assessment tools and experiential learning methods.

SPECIFIC ASSESSMENT TOOLS (to be used across the series of courses):


  • Myers Briggs Type Indicator (MBTI) preference and its use in learning/leading
  • Campbell Leadership Index (measures personal characteristics that are directly related to the nature and demands of leadership)
  • Life Review Questionnaire (self assessment of ten learning/life dimensions)
  • Emotional Intelligence (measures the style of learning, interacting with others as well as actual capacity)
  • Self Rating of MSTM Learning Objectives and Competency Levels

ETLS 550 Leveraging Leadership for a Lifetime I


(Offered as the initial course within the MSTM graduate program)
(One Credit Course) 

This course provides a comprehensive orientation to the newly accepted student in the MSTM program as well as launching the learning process for the upcoming three to five years. The student will build a base-line assessment of his/her competencies, values, learning style, leadership aptitude and personal/professional talents; build understanding of the graduate program’s mission, vision and values and its “fit” with participant’s values; identify key communication competencies that need strengthening; shape a learning plan that will serve as her/his contract for the next 3-5 years of professional life (graduate program, work, community, etc.); develop learning action steps that involve key stakeholders in their communities; and be assigned to a peer group that will serve as a support vehicle for applications of the learning process. Expectations for the learning process will be identified; tools for student evaluation of program outcomes selected; portfolio design/development will be outlined; and critical communications tools/methods will be examined.

ETLS 551 Strategic Quality Management

Strategic Quality Management is presented as a Driver → System → Results model.

The DSR model provides a framework for better understanding your business and when and where to take action to improve results. The model is a tool that links company mission, strategic plans, competitive positioning, and customer focus as the Driver. People and processes form the System that actually designs, produces, and delivers products and services. Results include financial, customer, employee, and process. This course also connects the DSR model with the Malcolm Baldrige Criteria for Performance Excellence, six sigma and lean improvement tools, ISO9000, and Quality Management Systems and tools such as Statistical Process Control (detailed training in tools such as SPC is not part of the class). In addition to developing an understanding of how to guide and manage quality strategically, the course also helps to identify and prioritize the "right questions to ask" to guide and manage tactically. Applying the course to real world situations should lead to improved results - financial, customer, employee and process.

ETLS 552 Supply Chain Synchronization

This applications-oriented course will review key topics in supply chain management and integrate these topics with current management thinking in lean manufacturing and six sigma. A systems thinking approach that maps logistics, forecasting, warehousing, transportation, and information systems will be combined with discussions of vendor and customer relationships, motivations, and ethics to work toward a smoothly functioning supply system. Students will use proven industrial engineering and management principles, techniques and tools to design a supply chain for their industry, efficiently and effectively plan and layout manufacturing operations, and improve processes to eliminate waste.

ETLS 555 Advanced Product Design

Detailed discussion of product development for design engineers.  This lecture-based course is instructed by a practicing medical device engineer using examples from industry projects.  Students will learn the full product development cycle from initial market analysis and concept development through manufacturing validation and product launch.  General design topics include: voice-of-customer research; technical product requirements; project planning and architecture; concurrent design and DFMA; prototyping; testing and analysis; design portability and manufacturing transfer; verification and validation; manufacturing process control; and post-market continuation engineering. 

ETLS 570 Purchasing, Logistics and Distribution

An introduction to the operations aspects of logistics combined with an overview of Supply Chain Management. Topics will include purchasing, vendor relations, inventory strategies and control, warehousing, material handling, packaging, and transportation, combined under supply chain management philosophy. The course will be taught through lectures, problem sets, case studies, guest speakers, and a tour of a high volume, order fulfillment facility.
Prerequisite: ETLS 505 Managerial Accounting and Performance Management is recommended but not required.

ETLS 571 Automation Systems in the US and Overseas

This course provides an examination of automation and the processes and systems in which it works. The course focuses on electronic, electromechanical, and mechanical manufacturing and also touches on highly automated molding and its tooling. Topics include flexible and hard automation within a variety of systems environments. The course moves from automation basics to designing for automation followed by a hard look at the processes such as group technology, sensors, and systems that allow for and improve automation. The course consists of lectures, guest speakers, videos, and visits to factories and laboratories.

ETLS 591 Advanced Thermal Systems

This course provides an overview of fluid mechanics and heat transfer with a focus on the design of thermal systems. These systems include applications in the biomedical, aerospace, manufacturing, HVAC, and electronic cooling.