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Medical Systems Engineering 5-Day Course
- 5 Days
- Corporate delivery (In-person or online)
- Certificate upon completion
- Professional Development Credits
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- Summary
- Course Overview
- Course Outline
The potential of systems engineering is extraordinary, and creates almost unlimited
opportunity for professionals with the practical skills and process understanding
needed to engineer systems and products more effectively. PPI’s approach to sharing SE uses
expert presentations, discussions, and team workshop activities. We cover core
areas of SE conduct, and explain how each of these elements functions within a
development system. You’ll discover that SE offers a rich body of sound engineering
and management methods that benefit the entire enterprise.
- This course may be credited toward the maintenance of the INCOSE Certified Systems Engineering Professional (CSEP) certification for 40 Professional Development Units and PDUs may be claimed for PMI’s family of certifications, including PMP
- This course may be credited toward the maintenance of the Project Management Institute (PMI) certifications. Suggested PMI Talent Triangle® PDU allocation:
- Technical Project Mgt – 35
- Leadership – 2
- Strategic & Business Mgt – 3
Let’s Talk
Whether you have a question or are looking to find out more about our training options then please get in touch with us below.
Key Learning Objectives
Upon course completion, participants will have the ability to create new value in many ways:
- Perform each of the major SE activities, and explain how the SE tasks are integrated into overall project execution.
- Translate fuzzy stakeholder intentions into valid and verifiable requirements, enabling manageable traceability between needs and solutions.
- View all requirements and design as a model, representable in many ways, and recognize when to invest in creation of MBSE and other formal expressions.
- Utilize SE to identify and champion the “voice of everyone” throughout the system life cycle, thereby eliminating entire classes of system risk exposure.
- Effectively apply the logic of SE to fit widely differing needs, ranging from selective use of a few key tools to substantial adoption on major developments.
- If appropriate, unleash your inner entrepreneur and use SE to launch the product of your dreams.
Training Method and Materials
The course makes extensive use of course workshops to put into practice the techniques covered in theory sessions.
The course is delivered using a mixture of formal presentation, informal discussion, and extensive workshops that exercise key aspects of a systems approach to design, using a single system throughout. The result is a high degree of learning, as evidenced by workshop work products, and the extensive commendations received from past participants.
Participants will be provided with:
- comprehensive course materials containing presentation material and supporting reading material;
- numerous supplementary descriptions, checklists, forms and charts which you can put to use immediately; and
- complimentary access to PPI’s evolving Systems Engineering Goldmine.
Who Should Attend this Course?
The course is designed with overall development success in mind, and balances theory with a host of practical tools, tips and pitfalls to avoid. Whilst valuable to anyone who holds development responsibility, the primary beneficiaries include:
- Project and program management
- Engineering leadership and all engineers
- Quality, security, specialty engineering areas, system testing, operations, and support
0. Introduction – Why Systems Engineering?
1. The System Life Cycle and Solution Development
- Systems thinking
- Defining “the problem”
- The solution domain: key concepts, relationships, information types and work products, Model-Based
Systems Engineering (MBSE) - Concept of Use (CONUSE)/Concept of Operations (CONOPS)/Operational Solution Description
(OSD)/Architectural Design Description (ADD) issues - Architectural frameworks
- Relationship between problem definition and stakeholder satisfaction
- Systems of systems engineering (systems of autonomously managed systems)
- Waterfall, incremental, evolutionary and spiral developments
- Concepts of agile, lean, scaled agile framework and concurrent/simultaneous engineering
- Product Line Engineering (PLE)
- Digital engineering, digital thread, digital twin
- Summary of key concepts
2. Systems Engineering Processes: Principles, Concepts and Elements
- Workshop – principles of the engineering of systems
- Design concepts
- The Wedge ModelTM– verification and validation
- SE process elements
- Requirements analysis
- Development of physical solution description
- Development of logical solution description-MBSE (model-based architecting/design)
- Effectiveness evaluation and decision – trade studies
- Specification of systems elements – specification writing
- System integration
- Verification and validation
- Engineering management
- Workshop – matching common activities to the SE process elements
- Work product attributes
- requirements traceability
- design traceability
- test/verification traceability
3. Systems Engineering Standards
- ISO 14971 – Medical Device Risk Management (MDRM)
- ISO/IEC 15288 – Systems Engineering
- standards pitfalls and pointer
4. Requirements Analysis
- What are requirements?
- Types of requirements, and how they relate to analysis, specification and design
- Requirements quality attributes
- Requirements languages other than natural: operational, formal
- Requirements Analysis (RA) – how to do it. MBSE in the problem domain
- Workshop – context analysis
- Workshop – design requirements analysis (interactive whiteboard exercise)
- Workshop – states and modes analysis
- Workshop – parsing analysis of example requirements
- Requirements quality metrics
- Workshop – functional analysis in requirements analysis
- Entity Relationship Attribute (ERA) analysis, rest of scenario analysis, out-of-range analysis, other
constraints search, stakeholder value analysis - Concept of Use (CONUSE)/Intended Use Description (IUD)
- Managing RA
- Requirements analysis and management software tools
- Common pitfalls in performing RA
5. Development of the System Physical Solution Description – Part 1
- Technology and innovation in solution development
- Configuration items
- Criteria for selecting configuration items
6. Development of the System Logical Solution (MBSE in Design)
- Types of logical representation
- Functional analysis in design – how to do it
- Functional analysis/architecture process
- Workshop – physical and functional design
- Performance threads
- Systems Modeling Language (SysML), Architecture Analysis Design Language (AADL) and other system
modeling languages - State-based modeling
- N-squared charts
- Analysis and design software tools
- Pitfalls in developing system functional solution
7. Development of the System Physical Solution Description – Part 2
- Review of progress against challenges
- Use of design driver requirements
- The system physical architecture related to the functional architecture
- Facilities, procedures and people
- The specification tree
- Object-oriented design
- Common pitfalls in developing system physical architecture
- Adding the detail to the design
- Design For Six-Sigma (DFSS): e.g., Design Of Experiments (DOE)
- Interface engineering
- Common interfacing pitfalls
8. Effectiveness Evaluation and Decision-Making
- Approach to design optimization
- The role of Measure of Effectiveness (MOEs) and goals
- Constructing a system effectiveness model
- Capturing utility functions
- Taking account of risk
- Iterative optimization of design
- Working with budgets, targets and ceilings
- Value engineering
- Workshop – engineering decision-making
- Multiple stakeholders, multiple uses, event-based uncertainty
- Pitfalls in effectiveness evaluation and decision (avoiding the smoke and mirrors)
9. Description of System Elements – Requirements Specification Development
- The eight requirement specification types and their uses
- Public specification standards – the good, the bad, and the ugly
- Specification structure principles
- Good and poor terminology
- Recommended Data Item Descriptions (DIDs) and templates
- Pitfalls in preparing requirements specifications
10. Engineering Specialty Integration (ESI)
- What makes an engineering specialty special?
- Common engineering specialties
- A generic approach to ESI
- Organizational issues of ESI
- Pitfalls, and specialty engineering examples
11. System Integration
- Integration planning
- Alternative system integration strategies
- Integration
- Integration testing
- Using incremental builds
- Configuration audits
- Qualification
- Pitfalls and pointers in system integration
12. Verification and Validation
- Verification and Validation (V&V) terms defined
- Lean concepts in V&V
- Technical reviews
- Requirements reviews
- Principles of design review
- Architectural Design Review (ADR) – relationship to Preliminary Design Review (PDR)
- Detailed Design Review (DDR) – relationship to System Design Review (SDR), Critical Design Review (CDR)
- Test Readiness Review (TRR)
- Requirements satisfaction audits (Functional Configuration Audits [FCAs])
- Design description (Build State-Build Standard [BS-BS]) audits (Physical Configuration Audits [PCAs])
- Technical reviews and incremental builds
- Administration of technical reviews
- Customer involvement in technical reviews
- Pitfalls in conducting technical reviews
- Test and evaluation
- Other verification and validation methods and tools
13. Systems Engineering Management
13.1. Engineering Planning
- Scoping SE – the Systems Engineering Plan (SEP), Systems Engineering Management Plan (SEMP)?
- Why prepare a SEP?
- How a SEP may relate to other plans
- Content of the SEP
- Pitfalls in preparing a SEP
13.2. Project Breakdown Structures (PBS/WBS)
- Types of PBS (Work Breakdown Structure [WBS])
- Why the PBS/WBS is a foundation of effective engineering management
- Rules in preparing a PBS/WBS
- PBS/WBS Standards and Guides
- Relationship of a PBS/WBS to cost accounts
- Relationship of a PBS/WBS to work packages
- PBS/WBS development pitfalls and pointers
- Integrated Product Teams
13.3. Configuration Management (CM)
- What is configuration?
- The concept and types of baseline
- CM standards – EIA, IEEE, etc.
- The four fundamental CM activities
- Pitfalls and pointers in CM
13.4. Technical Program Controls
13.5. Risk Management
- The nature of risk
- Components of risk
- The five key activities of risk management
14. In Closing
- Systems engineering summarized
- Tailoring to specific activities or projects
- Getting the most out of systems engineering methods
- Systems engineering capability assessment and improvement
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