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Product Systems Optimization

KKAI develops new products and manufacturing processes, and provides consulting services that maximize profitability for our clients.

The KKAI Product Systems Optimization Team is a world-class source of engineering design and problem solving skills applicable to all manufacturers. Working as an extension of your engineering staff or as a separate project team, we specialize in providing timely and cost-effective solutions for new product designs, older product upgrades and enhancements, power electronics engineering including commercial design of high power motor drives / inverters, control systems and switching power supply design, expertise in motor and drive system applications and design including AC, DC, Servo, PM AC (brushless DC) high speed and high power designs, and regulatory compliance assistance when dealing with various national and international regulatory agencies, all with the core objective of maximizing your profitability.

Additional related expertise includes Management of Product Design and Development, Development of Product Manufacturing Strategies, Optimization of Manufacturing Processes, Materials Selection for Manufacturing, Quality Assurance, Control, and Leading Program Implementation for Specific Products and Families of Products, Contract Manufacturing Project Engineering, New Product and Process Development, Six-Sigma Methodology, Geometric Dimensioning and Tolerancing Requirements, Gauging Methods, Process Analysis, and Machine Specification, Business Development, Creative Development, Program Management, Collaboration Management and Product Design, Corporate R&D, Strategic Issue Resolution, Technology Development, Laboratory Development, Regulatory Compliance, Mission-Critical and Safety-Critical Software, Firmware, and Embedded Systems Design, Development, Implementation, Troubleshooting, Medical Devices, FDA Regulatory Affairs, Quality Assurance, and Product Design, Management of Product Warranty Analysis and Reliability Engineering, Electronics Design, Electrical Hardware Design Engineering, EMC and EMI engineering, Power Electronics Engineering, and Motor and Drive System Applications and Design.

As an extension of our Organizational Mentoring^TM services, and as an integral part of our RAPID RESPONSE ENGINEERING® approach, key capabilities of our Product Systems Optimization team include:

• Engineering Design Services
  • Custom Embedded Control Systems
  • Analog, Digital, Mixed-signal designs
  • Complete Software Design & Support
  • Sensor Design and Integration with new or existing designs
  • New Product Design
  • Older Product Re-design reducing cost and obsolete components
  • Analysis, Debug and Re-Design of Existing Designs that are causing problems
  • Mechanical Design
  • PCB design, layout and schematic capture
  • Windows software development
  • Embedded Windows XP and CE development
  • Linux software development
  • Palm software development
• Regulatory Agency Assistance and Expertise
  • UL and UL1998
  • CSA
  • FM Approvals
  • Food and Drug (FDA)
  • FAA and DO-178B
• Failure Mode Effects Analysis (FMEA) -- design, process, manufacturing, hardware, software, mechanical
• Project Management and Planning -- With many years of experience in areas of technical project management, hardware and software design, and in the practical aspects of designing, developing, and bringing products to market, our technical experience has seen both sides of project development - the creative aspects of the design process and the planning, budget, control and administrative issues in project management.
  • Initial project design and specification, system specifications, development plans.
  • Project verification - design reviews, walkthroughs, peer-reviews, failure mode studies (FMEA).
  • Detailed system design - specification, prototyping, software design, documentation.
  • Test processes - Test plans and test procedure design and documentation.
  • System validation - independent validation of requirements to functionality
  • Results analysis, project summaries.
  • System and Engineering documentation required for industry or federal regulatory approvals
• System Integration -- Embedded Control Systems are computers (microprocessors) that are enclosed (embedded) in customized hardware. Examples of embedded control systems would be portable medical equipment, cellular phones, police, fire, emergency communications equipment, laboratory test equipment, robotic equipment and manufacturing monitoring of assembly lines. We provide digital signal processing (DSP) solutions for telecommunications, numeric processing, high speed control and instrumentation, and graphics and image processing. Our standard microprocessor designs include:
  • Intel 8051/8052 family
  • Motorola 68HC11/12/16/332 family
  • Intel 80x86/Pentium family
  • TI 320 dsp family
  • Microchip 16F873-877, 17C756/66, and 18C/F452 family
  • Cygnal 8052 superset family of devices
• Technical Documentation -- complete documentation services for use in planning, development, design and testing, as well as for compliance with industry or federal regulatory approvals (including ISO, UL, CSA, FDA, FAA, Factory Mutual, CE)
  • Initial project design or concept
  • Preliminary project development
  • Creation and implementation of project plans, procedures and documentation
  • Design of hardware and software
  • Prototyping of initial models and equipment
  • Initial development testing, design reviews, and design controls
  • Test and validation of complete system
  • Project analysis and validation results reports
  • System specifications and requirements
  • Software requirements specifications
  • Software Development Plans
  • Software Test Plans
  • FMEA studies (failure mode error analysis)
  • Standing Operating Procedures for design controls, reviews, quality control, verification and validation

By shifting development of key deliverables to KKAI's Product Systems Optimization team you can take advantage of our best practices capabilities and extensive experience to shorten development cycles, minimize fixed costs, facilitate regulatory compliance, and increase your return on investment.

Among our many specialties, we include expertise in Medical Device GMP and FDA regulatory compliance.

Products that require regulatory approval have added constraints placed on the methods and procedures used during the development process. Our extensive experience enables us to provide assistance with critical areas including:

• Project organization - documented project phases, milestones, and the methods and procedures for approvals and for moving from one project phase to another
• Identifing project and technical risks, and methods of mitigating those risks
• Requirements testing - methods and procedures for tracking software and hardware requirements through the design and testing process to ensure that those requirements have been fully tested
• Formal methods and procedures for system validation testing
• Tracking control of project history, design methods, and progress through the design, testing, and acceptance process

We also have extensive experience in DO178-B compliance for the avionics (aeronautical and aerospace) industry--which is among the most strictly regulated and tested of all industries. Following is a list of activities and associated deliverable that are expected as part of the overall process.

Planning

• Plan for Software Aspects of Certification
• Software Project Plan
• Software Verification Plan
• Software Configuration Management Plan
• Software Quality Assurance Plan

Standards

• Software Requirement Standards
• Software Design Standards
• Software Code Standards
• Software Verification Standard
• Software Documentation Standard

Development

• Software Requirements (high-level requirements)
• Software Design (low-level requirements)
• Software Design (architecture)
• Software Code

Software requirement verification

• High-Level Software Requirements comply with System Requirements
• High-Level Software Requirements traceable to System Requirements
• High-Level Software Requirements accurate and consistent
• High-Level Software Requirements compatible with hardware
• High-Level Software Requirements are verifiable

Software design verification

• Low-Level Software Requirements comply with High-Level Software Requirements
• Low-Level Software Requirements traceable to High-Level Software Requirements
• Low-Level Software Requirements accurate and consistent
• Low-Level Software Requirements are verifiable
• Software Architecture complies with High-level Software Requirements
• Software Architecture traceable to High-level Software Requirements
• Software Architecture accurate and consistent
• Software Architecture compatible with hardware
• Software Architecture is verifiable
• Software Architecture conforms with Software Standards

Software code verification

• Source Code complies with Low-Level Software Requirements
• Source Code traceable to Low-Level Software Requirements
• Source Code complies with Software Architecture
• Source Code is traceable to Software Architecture
• Source Code is accurate and consistent
• Source Code is verifiable
• Source Code conforms with Software Standards

Verification of integration process

• Ensure testing methodology of Software Verification Plan was used
• Ensure test cases are accurately developed to meet requirements and coverage
• Ensure verification results are correct
• Object Code complies with High-Level Software Requirements
• Object Code is robust with regard to High-Level requirements
• Object Code complies with Low-Level Software Requirements
• Object Code is robust with regard to Low-Level Requirements
• Object Code is compatible with target hardware
• Object Code complies with Software Structure (where applicable)

Verification of verification process

• Test Procedures are correct
• Results are correct
• Compliance with Software Verification Plan
• Test coverage of High-Level requirements
• Test coverage of Low-Level requirements
• Test coverage of object code
• Test coverage - Modified condition/decision
• Test coverage - Decision
• Test coverage - Statement
• Test coverage - Data coupling and Control coupling

Configuration management

• Configuration items are identified
• Baselines and traceability are established
• Problem report, change control, change review, and configuration status accounting are established
• Archive, retrieval, and release are established
• Software load control is established
• Software life-cycle environment control is established

Software quality assurance (sqa)

• Assure transition criteria for software requirements process
• Assure transition criteria for software design process
• Assure transition criteria for software code process
• Assure transition criteria for software integration process

Why Organizational Mentoring^TM?

KKAI's Organizational Mentoring^TM capabilities take the term "consulting" to an unprecedented level of service. Through this unique and innovative approach, KKAI world-class experts and consultants virtually work side-by-side with individuals within your organization or other remote or on-site KKAI support staff via Microsoft Terminal Server technology. It is accessible 24x7, from anywhere in the world, enabling KKAI experts to share applications and work with the client, on the client's desktop in real time. In addition, you can realize effective recruitment of On-Site Engineering, Technical, and Managerial expertise, combined with the benefits and flexibility of engaging Short-Term Consulting and/or Long-Term Consulting services. The result is the most focused and efficient means of utilizing and employing the world-class expertise that is available to you through KKAI. Follow this link to learn more.

Failure Analysis and Forensic Engineering

• Electronics and Electrical Failure Analysis
• Electrical Motors, Drives, and Power Systems
• Pumps, Powertrains and Transmissions, and Turbines
• Metallurgists, Glass, and Ceramics
• Corrosion and Coatings
• Polymers, Adhesives, and Packaging
• Welding, Soldering, and Brazing
• Product and Workplace Safety, Fire Safety and Investigations
• Wear, Lubrication, and Friction

Other integral aspects of the RAPID RESPONSE ENGINEERING® approach include Materials Technology Consulting, Product Development and Design Consulting and Manufacturing / Quality Consulting, and Discrete Event Simulation / Finite Element Analysis.

By taking advantage of our extensive experience in engineering for product / manufacturing, it is possible to shorten your design time and meet your performance goals.

Whether acting as an extension of your engineering staff, or as a separate project team, the KKAI Product Systems Optimization Team provides solutions to your most difficult development challenges.

When combined with other KKAI expertise in Materials Technology, Product Development and Manufacturing Systems, and other "special service" teams such as the In-Depth Failure Analysis and Forensic Engineering Team, or the Performance Testing Services Team, you can realize a total technological solution with the convenience of "one-stop shopping."

Examples of our Product Systems Optimization Capabilities include:

• Medical
• Automotive
• Steering Systems
• Powertrain
• Suspension
• Power Plant
• Agricultural

When combined with our capabilities in Engineering, Inspection, and Validation Testing, the KKAI Product Systems Optimization Support Group can be the answer you have been seeking.

Please note the special capabilities and expertise of KKAI in Lean Manufacturing Consulting, Seminars, Training, and Implementation, enabling us to identify and implement cost-savings procedures within the parameters of your existing manufacturing system.

Product Design and Manufacturing

• Analysis and Design of Manufacturing Processes, Machine Design, Automotive Durability, Noise and Vibration Abatement, Crashworthiness, and Occupant Safety, Structural and Thermal Systems, and Electronic Devices, including the Applications of Finite Element Analysis (FEA) and Computer Assisted Engineering (CAE) in Continuum Mechanics, Electro-Dynamics, Fluid and Gas Dynamics, Heat and Mass Transfer
• Mechanical, Electrical, Semiconductor, Electronic, Chemical, Software, Structural, Industrial, System, Manufacturing, Quality, Control, Packaging Engineering for all industries, and Metallurgical Engineers, Consultants, and Experts
• Pharmaceuticals, Dietary Supplements, Foods, Cosmetics, Houshold Chemical Specialties, Life Sciences Consulting in all areas of the Biotechnology, Bio-Pharmaceutical, Molecular Diagnostic, Medical Device and Equipment Industries, Health Care Products and Packaging, Quality Control, Assurance, and Good Manufacturing Practice (GMP) Compliance and Validation Expertise including Executive Management Consultants, Ph.D. Scientists, Project Managers, Manufacturing Engineers, QA, QC and Regulatory Compliance Specialists, and M.D. Clinical Trial Experts
• Mechanical, Hydraulic, Electro-mechanical, and Electronic Devices, and Systems Design, Development, Reliability, Life Cycle, and Manufacturing Consultants, and Experts
• Pharmacology, Toxicology, and Dermatology

Follow these links to more KKAI capabilities.

• Lean Transformation
• Manufacturing Optimization
• Testing Capabilities

If you have not found the specific expertise you are seeking, please use our search engine, or for immediate assistance call 1-800-367-5524.

Following are capabilities of specific KKAI Product Optimization Consultants, demonstrating a sampling of the world-class expertise and experience available to you.

• Product Design and Development
• Electronics Specification Negotiation
• Digital and / or Analog Design
• QS 9000 and ISO 9001 Program Practices
• Electronics and Mechanical Computer Modeling
• Environmental Testing
• Manufacturing
• Failure Analysis, Failure Physics
• Automotive Systems, Automotive Electronics and Reliability, Automobile Ignition
• Chip Shooters
• Circuit Board
• Cold Welding
• Diesel Glow Plug Control
• Electric Vehicle Power Controllers
• Electronic Knock Control, Electronic Spark Control
• Electronics Packaging
• HALT - Highly Accelerated Life Testing
• HAST - Highly Accelerated Stress Testing
• Hybrid Circuits, Hybrid Electronics, ICs, Integrated Circuits
• Ignition Systems
• Life Testing
• Mass Air Flow, Mass Air Sensors, Mass Flow Sensors
• Pick and Place
• Position Sensors, Pressure Sensors
• Power Electronics, Power Modules, Power Transistors
• Reliability Testing
• Thick Film Circuits
• Transistors
• Up-Integration
• Vehicle Power Switch
• Voltage Regulation

• Product Manufacturing Strategies, Optimization of Manufacturing Processes, Materials Selection for Manufacturing
• Quality Assurance, Control
• High-Volume Assembly, Electronics, Semiconductor, and Consumer Product Manufacturing
• Hybrid
• PCB (printed circuit board) and PWB (printed wiring board) Packaging
• Design for Mechanical Assembly
• Wave Soldering and Metal Surface Finishing
• Flip Chip Applications
• ABS Applications
• Thermal Package Design
• Thermal Buffer Systems for Power IC's
• High Density PWB's
• Flexible Robots
• Surface Mount Technology, SMT Testing

• Manufacturing Engineering
• Industrial Engineering
• Contract manufacturing project engineering
• New product and process development
• Six-sigma methodology
• Geometric dimensioning and tolerancing requirements
• Gauging methods
• Process analysis
• Machine specification
• PFMEA's
• Production readiness plans
• International training experience
• Plant layout
• CNC program development
• SPC implementation
• Lathes
• Machining
• Grinding
• Broaches
• Washers
• Deburring
• Roll forming
• Machinery purchase
• QS9000 implementation
• Tooling

• Leadership, Management
• Product Design / Development
• Technology Development
• Systems Engineering
• Manufacturing Engineering
• Business development
• Creative development
• Program management
• Collaboration management and product design
• Corporate R&D
• Strategic issue resolution
• Technology development
• Laboratory development
• Materials
• Telephony and fiber optic systems
• Optical engineering
• Risk management
• Group decision making
• GMP
• ISO 9000
• Quality improvement (Deming)
• Management of technology development
• Matrix management
• Computer architectures
• Distributed processing
• Polymer processing
• Fiber optics systems design
• Lens design
• SONET
• Telecom systems
• LAN architecture
• Extrusion melt processing
• Photonic component design
• Integrated optical systems
• ProE, SolidWorks, 3D Studio Max
• Object oriented programming
• Clean room design
• Thin film processing
• Vacuum system design
• Extrusion screw design
• Single board computers
• Unmanned aerial vehicles
• Performance management
• Management training
• Engineering management, scientific and technical staff management
• Communications product design and engineering
• Pharmaceutical manufacturing engineering

• Regulatory Compliance
• Mission-Critical and Safety-Critical Software and Firmware Design
• Implementation, Troubleshooting, Programming Design
• Embedded Systems Design
• Lifecycle Planning
• Requirements Engineering
• Metrics Analysis
• Failure Mode Effects Analysis (FMEA)
• Documentation
• Software Development Plan
• Requirements Documentation
• Test Plan (Use Case)
• Verification and Validation Plan (V&V)
• FDA related Quality Systems Regulations (QSR) to 21 CFR Park 820
• Medical Device Design Procedures to 21 CFR 803, 806 and 821
• Quality System Inspection Procedures
• Good Manufacturing Practices (GMP)
• Methods and documentation suitable for regulatory agency approvals (ISO, UL, CSA, FDA, FAA, Factory Mutual, CE)
• Experience with regulatory agencies (UL, CSA, FDA, FAA, Factory Mutual, CE)
• Problem-solving
• Team facilitation
• Coworker mentoring
• Quick product development
• Review of new technologies, prototypes, and designs with regard to emerging and expanding businesses

• FDA regulatory affairs services for the pharmaceutical and medical device industry
• FDA regulatory auditing
• ISO 9001 and cGMP compliance
• CE Marking guidance
• FDA submissions: 510(k), PMA, IDE
• Process, Product, Software Validations
• FDA-483 and Warning Letter responses

• Management of Product Warranty Analysis and Reliability Engineering
• Mechanical Engineering, Electronics Product and Process Validation, Failure Physics
• Design of Mechanical Sensors and Control Systems
• Quality Engineering, Validation/Verification
• CALCE - Computer Aided Life Cycle Engineering
• ALT - Accelerated Life Testing
• HALT - Highly Accelerated Life Testing
• HAST - Highly Accelerated Stress Testing
• HASS - Highly Accelerated Stress Screening
• Accelerated Life Test Models
• Mechanical Design
• FMEA - Failure Modes & Effects Analysis
• Warranty Analysis
• QS 9000
• Reliasoft Software
• Weibull
• Life Data Analysis
• Math Modeling, Common Design Engineering Process
• Shainin
• Environmental Testing
• Engineering Documentation
• Mechanical Packaging

• Electronics Design, Electrical Hardware Design Engineering
• EMC and EMI Engineering
• Failure Analysis and Forensic Engineering
• Agency Standards (UL, CE, CSA, FCC & IEC)
• Grounding
• Computer Engineering & Applications, High Speed Data Networks
• Electrical Devices/Equipment
• Industrial Automation & Controls
• Product Testing
• Electrical Systems, Semiconductors, Electrical Safety
• Telecommunications
• Electronic Manufacturing, Quality Control
• Analog and Digital Design
• Integrated Circuit Design
• EMF & EMI Shielding
• IP - Internet Protocol
• Electromagnetic Compliance Testing, Lightning/Surge Protection and Analysis, ESD - Electrostatic Discharge
• Microprocessor Design & Applications
• Ethernet
• Printed Circuit Board Design and Analysis
• FMEA - Failure Mode & Effect Analysis
• Programmable Logic Controllers
• Fiber Optics, RS232, FPGA Design, Signal Integrity and High Speed Design
• SONET, HDLC, Protocol
• Telecom and Data Communication

• Power Electronics Engineering
• High Power Motor Drive /Inverter Design (from below 1KW to 1MW)
• Control Systems, and Switching Power Supply Design
• Electronic Design, Product Qualification, Managing Small Engineering Teams

• Motor and Drive System Applications and Design: AC, DC, Servo, PM AC (Brushless DC)
• High Speed and High Power designs
• Coordinated Multimotor System Integration
• Traction, Metals, Paper and Plastic, Plastics, Wire, Textile, Conveyors, Process Loops, Positioning and Material Handling, Web Handling and Draw Processes
• PLCs, Operator Interfaces
• Panel Design and Building
• Installation and Troubleshooting
• Circuit Design: Analog, Digital
• Power Electronics
• Embedded Microcontrollers
• Electrical Power: UL, NEC, UL Panelbuilder Program
• Protective Systems
• Electrical / Electronic Test Systems
• Automotive and Aerospace Test Stands
• Manuals and Procedures
• Technical Sales
• Costing and Proposals
• Project Management
• Instruction and Training
• Lead Engineer
• Supervisory and Staff positions
• Hands-on working knowledge in Hydraulics, Pneumatics, Mechanical, Structural and Piping Systems
• Electrical and mechanical subsystems
• Industrial controls systems and processes

Metallurgy

	Failure Analysis of Turbine Blade
	SEM Micrograph of a Crack Surface
	Optical Micrograph of a Turbine Blade
	Fracture Surface of a Sector Shaft

Medical Devices

	Electrosurgical Ball Electrode
	Angioplasty Balloons

Virtual Prototyping of New Products

	Download/play a CFD analysis / simulation of the air flow through the engine air inlet system of an Indy Racing League car. (Playable with QuickTime Player)
	Download/play a CFD analysis / simulation of how the fuel flows into the fuel tank of an Indy Racing League car in order to reduce the fill time. (Playable with QuickTime Player)
	Download/play a simulation of a CFD analysis / simulation of how the air/fuel mixture flows through the catalytic reacter in a natural gas turbine engine to improve efficiency. (Playable with QuickTime Player)
	Download/play a crash / crashworthiness / accident simulation of a race car design (Playable with QuickTime Player)
	Download/play a crash / crashworthiness / accident simulation of a race car design (Playable with QuickTime Player)
	Download/play a crash / crashworthiness / accident simulation of a race car design (Playable with QuickTime Player)

Following are links to the resumes of a select few of many KKAI Consultants, Engineers and Experts with related expertise.

Review the resumes below, or enter your search query (type of expertise you are seeking) in the box below, choose to search the entire Rapid-Response site or just resumes and brochures, then click the search button. Please note that the list of resumes available online is a select subset of our vast database. If your search of our site does not reveal the expertise you are seeking, please call us toll-free (in the U.S.) at 1-800-367-5524 or email us at Rapid-Response@Organizational-Mentoring.com and we will gladly assist you in locating the specific expertise you require.

Kevin Kennedy & Associates, Inc.
Rapid Response Engineering (TM) Solutions
3815 River Crossing Parkway, Suite 100
Indianapolis, Indiana 46240
(317) 299-5528
(317) 299-5543 fax
rapid-response@kkai.com