Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT

**** ****** *****, ******, **** 45429, mobile: 513-***-****, adx27l@r.postjobfree.com

Executive Summary of Thomas Viggiano:

Business mentor and manager with a passion for: manufacturing, operations management, purchasing, supply chain, quality, engineering. A master black belt in both lean and six-sigma. I help manage operations which increase profits to companies on average of about $40,000,000 per year for the last 20+ years. I do enjoy doing so. I’ve managed groups of over 400 people to get the jobs done.

Results: I have a proven record of accomplishments of exceeding goals and increasing bottom-line profitability to about $40,000,000/year on average. I can balance the delivery of programs against the realities of a budget. Along with good problem-solving skills, project management, and creative resourcefulness that get the job done and increase profits.

I am a waste eliminator, profit generator and mentor. I’m a Master Black Belt in both Six-sigma and Lean, Achieving Competitive Excellence (ACE) and Shainin (Red-X) approaches. I am skilled to help with the transitional experience in training, facilitating and mentoring of people and programs. Transforming waste into millions of dollars of increase profits and I love doing so.

I am a United States of America (USA) citizen.

Education:

Master of Science in Manufacturing Management (MSMM), Kettering University, Flint, MI, Graduated in 2012 with a GPA of 3.84

Master of Science in Operations Management (MSOM), Kettering University, Flint, MI, Graduated in 2003 with a GPA of 3.95

Bachelor of Science in Engineering (BSE) - Mechanical Engineering, University of Cincinnati, Cincinnati, OH, and Graduated in 1996 with Cum Laude honors with a GPA of 3.6

Associates in Applied Sciences Mechanical Technology (AASMT), Westchester Community College, Valhalla, NY, Graduated in 1982, GPA of 2.5

Experience Summary:

Project Manager Sr. Program Manager

Sub-Section Manager Supply Chain Manager

Risk, Issue and Opportunity Management Master Black Belt Six-sigma and Lean

This is a one-page resume: The following pages are supporting documents to the first page.

“Increasing profits of companies by an average of over $40,000,000/year, and managing groups of over 400 people”

Continued Experience Summary from first page:

Business Analysis Asset Manager

Sr. Efficiency Engineer Sr. Project Manager

Sr. Industrial Engineer Sr. Value Engineer

Sr. Machine Design Engineer Shainin approach

Lead Manager Achieving Competitive Excellence (ACE)

Intergraph, Pro-Engineering Sr. Manufacturing Engineer

Sr. Mechanical Engineer Liaison Engineer

Sr. Product Engineer Sr. Statistical Engineer

MS Project Sr. Project Engineer

Performance Engineer Sr. Quality Assurance Engineer

Quality Control Engineer Finance Director

Sr. Assembly Line Engineer Systems Management

Technical Writer AutoCAD, Minitab

CAD/CAM-SDRC IDEAS/CAEDS Tool & Die Maker, Machinist

Designer/Draftsman Safety Engineering Consultant

Operations Engineering Cost Improvement Manager

Cost Engineer Cost Czar

Consultant Commodity Performance Management Specialist

Safety Process Engineer Environmental, Health and Safety Engineer

Reliability Engineer Complaint Engineer

Human Factors Engineer Organizational Change Management

Instructional System Specialist Human Resources

Organizational change agent, next generation corporation management, program consultant. Project Lead Manager

Work Experience:

Phillips Ultrasound, Philips Sleep and Respiratory Care, Hospital Patient Monitoring Under contract. February 2023 to May 2023

Pittsburg, PA, Reedsville, PA, Monroe, PA

Senior Source Quality Engineer, Supplier Quality Engineer, Lead Engineer.

Managing vendor supply.

Responsibilities:

1. Responsible for achieving a state of high-quality performance at our supplier partners through the application and practice of Advanced Product Quality Planning (APQP) during industrialization of Philips products/parts within the New Product Introduction (NPI) process.

2. Participate in supplier sourcing process.

3. Quality engineering capability assessment of potential new suppliers.

4. core member of project teams.

5. Drive APQP plan development, Execution, Monitoring and control as part of the transfer process.

6. Contribute to supplier project book content.

7. Support Design for excellence "DFX " collaboration between R& and Supplier.

8. Ensure critical to quality characteristics are flown down to supplier.

9. Part submission warrant plans, Deliverables, Line release and completion.

10. Drive supplier quality improvement and development through APQP.

11. Strong technical/Documentation skills for regulated medical devices design environment, including requirement definition

12. Demonstrated ability to effectively work with cross-functional stakeholders to ensure the design meets their expectation and needs, and that requirements are properly documented.

• Supplier Quality Engineer with experience in Electro-Mechanical sub-systems and systems.

• Process validation: Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) (IQ/OQ/PQ)

• Risk management.

• FMEA

• Knowledge of ISO 13485/9001/FDA

• GD & T

• Knowledge of Manufacturing Quality systems and working in a regulated industry

• Statistical Methods/MSA/Acceptance sampling.

• Supplier coordination

Course taken: ISO 13485:2016, Information Security Management Systems.

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 820 QUALITY SYSTEM REGULATION

Corporate Integrity Agreement Covered Persons course: Compliance Training forcovered Persons.

Johnson and Johnson, DePuy Synthes, Orthopedics Under contract August 2021 to September 2022

Warsaw, IN

Supply Chain, Project Lead, External Manufacturing Operations, RY Technical Operations, Transfer Project Leader – Engineer, External Manufacturing, Process Engineering, Manufacturing Engineering, Supply Chain, Staff Product Development Engineer, Quality Engineer, Remote working.

Key responsibilities:

Vendor selection, process - Best Value Decision matrix.

• Develop project schedules, project timelines and work breakdown structure

Manage the finance details of the projects

• collaboration across cross-functional resources to accomplish actions on-time or ahead of schedule

• Prioritize resource allocations across multiple projects

• Lead Product Transfers at Suppliers

• Set, track, and communicate metrics, goals, and objectives

• Execute Quality System requirements for Supplier Activities including Change Orders/Supplier Change Request, PFMEA, engineering studies, verification/validation protocols and reports

• Support Quality Event Resolution

• Provide timely and accurate project status reporting and escalations to executive stakeholders

• Develop strategic alliances across functions, business units, and geographic boundaries to achieve effective outcomes over the long-term

• Evaluate and implement processes and programs to improve product quality, reduce cost at supplier

• Manufacturing, quality and process engineering

• Working with various functional teams in supplier organization

• Process validations/verifications and PFMEA

• Preparing, reviewing and approving technical documents

• Lean Engineering

• Cleanliness, Sterilization, and/or Packaging

• Regulated industry, FDA, ISO, etc.

• Six Sigma and Statistical Engineering

Mechanical product engineering/product development. Strong experience New Product Development (NPD) product sustenance

Design for Manufacturability (DFM) discussions and negotiations with manufacturing department/suppliers

Experience in design and process Verification and Validation (V&V) to take decisions on design verification requirements and guide cross functional teams such as design, testing, engineering analysts and manufacturing to execute required design and process Verification and Validation.

Work with cross functional teams in Research and Development (R&D), manufacturing, supply chain, quality and regulatory affairs

Risk Management in a regulated industry through techniques such as Design Failure Mode and Effect Analysis (DFMEA)

Project Management – capability to own the commitment and delivering to agreed timescale of the project

Propose creative solutions to solve design problems.

Ensure design verification and validation is performed such as tolerance analysis, FEA, lab testing where appropriate to demonstrate that safety and efficacy are maintained in design of new products.

Update various product development deliverables as required

Ensure compliance with statutory regulations.

Interact with all levels of management, external experts and vendors.

Provide updates to management regarding work performed & deliverables and mitigate any project risks.

Manage supply change requests.

21 CFR Part 820, ISO-13485, and/or EU MDR

ISO 14644 Clean Room, ISO 7, class 8 clean rooms

My work helped increase profits and opportunities to over $4,000,000/year.

Trenton Corporation, Under contract August 2020 to October 2020

Ann Arbor, MI

Organizational change agent, next generation corporation management, program consultant.

Define the scope and needs for current and future (1, 5 year and 10 years) implementation plan for the corporate staffing. Measure and analyze current and future needs to right-size the corporation for future growth. Improve and projecting into the future the corporation staffing needs. Define human resources needs for the implementation plans. Work with quality engineering and quality control to improve quality issues, reduce waste and increase profits. The company is ISO-9001 register. Work with Maintenance department to improve life of equipment through a predictive and preventive maintenance program. Used Master Black Belt in Lean and 6-Sigma techniques. Move to a more controlled management system, implement lean, six-sigma and continuous improvement into operations and management. Conducted opportunity sessions with personnel to help create a vision of growth and increase profits from the implementation of their opportunity proposals. Improve Environmental Health and Safety (EHS) program and reducing ergonomic risk. Provided a general comparison of their current maintenance, process and quality programs bench marking to industry best practices. Increase output by 63%, while reducing staffing requirements. Estimated increase in profits $1,250,000/year.

Wright Patterson, Air Force Research Laboratory. Under contract June 2017 to May 2019 Dayton, Ohio

Healthcare Systems Engineer, Human Factors Engineer, Instructional System Specialist and Program Management in the Air Force Research Laboratory (AFRL)

Program management office managing the coordination of activities:

Management consultant in Healthy and Performing Populations, Human Factors Engineer, Systems Engineer, and Instructional System Specialist. Within the 711 Human Performance Wing in Air Force Research Laboratory (AFRL) Program Management. Providing development support to the base operational medicine clinic, continuous process improvement training. Develop agile training materials and provide the training to the Major Commanders. To help maximizes the value for the patient. Goal is to have zero harm; first do no harm. Identifying the current state outlines some of the challenges in the current system that will help illustrate the areas of opportunities. These opportunities statements are not reflective of individual performances or leadership, but instead highlights the variability in the systems and some of the limitations and external forces affecting our current performances. Using methodologies such as: Algorithms, Analysis, Design, Development, Implementation and Evaluate (ADDIE) and Specific, Measurable, Attainable, Results and Timely (SMART), Eliminating Waste: Defects, Overproduction, Waiting, Non-Standard over processing, Transportation, Intellect, Motion and Excess inventory (DOWNTIME), Agile, and others to improve their health care processes. Creating a continuous process improvement (CPI) environment to ensure a continuous improving healthcare system. Working to MIL-HDBK-520A, system requirements document. Organizational Change Management (OCM). Clearance: Tier 1 level, National Agency Check with Inquiries (NACI). Increase available man-hours and opportunities to over $3,500,000/year.

Tyco Electronics, TE Connectivity Under contract November 2014 to February 2017

Middletown, PA

Lead Manager of Quality Engineering, Research and Development to Production Consultant

Management consultant in advanced quality engineering and mentoring management at all levels at multiple client and vendor sites and their multiple customer’s sites. Coordinating multiple sites transfers within the United States and China. Winner of New Innovation Award while giving Extraordinary Customer Experience (ECE). There was significant improvement in our delivery times, lead times and responsiveness to exceed customer expectations every time. There were two manufacturing location changes, and both had safe launch approaches. Help move a semi-production project from the research, development phase within the United States to another location within the United States and moved the full production work to China. Help train the China workers for the production phase of the project. At times worked as a Master Black Belt in Lean and Six-sigma and used many techniques to help expedite the program schedule at the lowest cost. Organizational Change Management (OCM). The main plan is providing data analysis and developing designs for data communications, cable fiber optics and high-speed cables for servers. Help within the design and development to production of the new products. I trained both the customers and the internal staff on Design for Manufacturing (DFM), Cost Reduction, Corrective Action and Preventive Action (CAPA), Value Added and Non-Value Added, Irreversible Corrective Action (ICA) approaches.

• Review customer quality specifications.

• Provide design input on critical dimensions and methods of inspection

• Facilitate Failure Mode and Effect Analysis (FMEA’s) for Design & Process including periodic updates

• Help develop error-proofing techniques on all designs and processes.

• Develop and maintain Quality Inspection Plans (QIP’s) for components and assemblies

• Arrange for the design and fabrication of gages and inspection tooling.

• Verify repeatability and reproducibility of measurements.

• Provide data analysis and statistics summaries for parts produced on new tooling and help identify where process or tool changes to meet specifications.

• Support process validation studies for special processes. Be a resource for design of experiments (DOE) and capability studies.

• Evaluate suitability of inspection methods and recommend alternative devices to improve repeatability and reproducibility of measurements.

• Perform gage studies on critical measurement devices.

• Develop and facilitate plans to verify process performance when tools are transfer to an alternate manufacturing location.

• Facilitate cause and corrective action responses related to customer complaints.

• Support compliance to Quality Management policy (QS-9000 etc.) for new product introductions.

• Provide special reports and data summaries as required by key customers to gain their approvals of new products.

• Production Part Approval Process (PPAP)

• Advanced Product Quality Planning (APQP)

8D: Discipline 1 - Organize and Plan

Discipline 2 - Describe the Problem

Discipline 3 - Containment Plan

Discipline 4 - Describe the Cause

Discipline 5 - Permanent Corrective Action Plan

Discipline 6 - Verification of Corrective Action

Discipline 7 - Prevention of Recurrence

Discipline 8 - Communicate Success

5C:

1)Characterize

2)Containment

3)Cause

4)Corrective Action

5)Closure

Measurement Capability and Analysis (MCA) and Correlation. Gauge Repeatability and Reproducibility (Gauge R&R) and Accuracy testing.

Making chip to input output (I/O) cable assemblies with 25G per channel data transfer that involves data communication for end-customers with targeted high-end servers.

Use JMP11 a statistical software package.

Enterprise Resource Planning (ERP) System, SAP, GUI, Version 7200

Inspection Data Collection System (IDC)

Communications: Data and Devices, and Fiber Optics

Increase profits and opportunities to over $41,500,000/year.

Hill-Rom Inc. Under contract August 2014 to September 2014

Batesville, IN

Complaint Investigation Engineering Consultant

Managing the coordination of activities:

Analyze design related complaints, evaluate product (component) returns, complete root cause analysis on returns, complete engineering investigations and write a technical report. Govern by CHAPTER I--FOOD AND DRUG ADMINISTRATION (FDA), DEPARTMENT OF HEALTH AND HUMAN SERVICES. Use many Master Black Belt 6-sigma and Lean techniques to resolve issues. Used: People-soft, Agile, Product Life Cycle Management and IBM rational DOORS. Quality Assurance / Regulatory Affairs (QAC/RA), Corrective and Preventive Action (CAPA), FDA 21 CFR 820, ISO 9001, ISO 13485, ISO 14001, ISO 17025 and European Union Medical Devise Directive (93/42/EEC), Healthcare Canada Medical Device Regulations (SOR/98-282), Japanese Medical Devise QMS, Ministerial Ordinance No. 169 ad No. 2. Food and Drug Administration (FDA) Part 820 – Quality Systems Regulation – Subpart M – Records – 820.198 Complaints. Current Good Manufacturing Practice (CGMP). This is a medical device company.

Help to avoid a Food and Drug Administration (FDA) shutdown and penalties of over $80,000/day. Increase profits an additional $32,000/day from other issues. Increase net profits gain of $112,000/Day. This is a gain profit rate of $40,000,000/year.

The Doncasters - Meco, an Integrated Energy Technologies, Inc. Under contract

Paris, IL May 2014 to May 2014

Quality Engineering Consultant

Prepares advanced quality planning documents and participates in quality planning activities; including Failure Mode and Effect Analysis (FMEA’s), Process Flow Diagrams, Control Charts, and Gage Repeatability and Reproducibility (Gage R&R) and capability studies. Using Epicor software to manage projects.

Performs technical and statistical investigations and analysis on production, quality, process, and equipment issues using standard NAL problem solving method

Coordinates the resolution of quality issues and implementation of countermeasures with other NAL departments and suppliers

Serves as the primary liaison between NAL and customers on all quality related issues

Performs other duties as assigned

oTechnical knowledge in statistics and/or QC tools inspection methods

oComputer Aided Design (CAD), Geometric Dimensioning and Tolerancing (GD&T), and Advanced Product Quality Planning (APQP)

International Traffic in Arms Regulations (ITAR)

Export Administration Regulations (EAR) Foreign National Export License

Help to regain access to self-release parts and increased profits over $600,000/year.

The Coca Cola Company Under contract October 2013 to February 2014

Atlanta, GA

Manager, Reliability Engineering Consultant

Manage the coordination of activities with The Coca Cola Company and vendor’s base out of India and others. Manage the design and reliability of new equipment and be the liaison manager for the company. Manage consultants, designers, engineers and coordinators. Product Implementation Manager. I am a Master Black Belt in Lean and Six Sigma using the skill sets: Design of Experiments (DOE), Design for Six Sigma (DFSS), Reliability, and Statistical Process Control (SPC) statistical analysis on this project. Worked with New Product Development (NPD) and Integrated Product Development (IPD) Teams. Build Reliability block diagrams and reliability predictions, reliability testing and field failures analysis. Design Failure Mode and Effect Analysis (DFMEA) and Reliability Allocation: Agree Method, ARINC apportionment method, equal apportionment method. Product Life-Cycle Management (PLM, PLCM), Change Management (CM). Unit shall be in accordance with applicable safety and regulatory requirements (2006/42/EC for the EU) and risk assessment per EN12100. Manage the cost, time and deliver of the project. I preformed data analysis to estimate and then generate risk analysis. Govern by CHAPTER I--FOOD AND DRUG ADMINISTRATION (FDA), DEPARTMENT OF HEALTH AND HUMAN SERVICES. Used Windchill. I helped saved $150,000,000 on issues and opportunities in service reduction by redesigning the units with irreversible corrective actions and in cost reduction of high-risk issues.

Xerox Under contract April 2013 to June 2013

Middletown, OH

Environmental, Health and Safety Process Engineering Consultant

Assist in developing the process for the warehouse manufacturing operations to obtain a Responsible Recycling (R2) certification building on the existing ISO14001 documentation already in place. Work to the BS-OHSAS-18001 and ISO-18001 Occupational Health and Safety Management Systems Requirements. Create an Environmental Health and Safety (EHS) Management System (EHSMS). Design processes and equipment related to the creation of products or services that are cost effective and in keeping with the given budget. Work life cycle management including end of life management programs. Implement process designs, creating prototypes, testing, making necessary modifications where required and commissioning the process. Help address the Heating Ventilation and Air-condition (HVAC) systems and lighting systems issues with in the facility. Assess environmental health and safety requirements and ensure that they integrate into the process. Work closely with other professionals such as upper management, scientists and other engineers on development and research projects. Integrate new technology or environmentally friendly practices into existing processes. Ensure Product Life-Cycle Management (PLM) (PLCM). Used Master Black Belt (MBB) Lean Six-sigma approaches: Define, Measure, Analyze, Improve and Control (DMAIC): A standard approach for re-engineering existing processes. Overview examples shown below. Define Measure, Explore, Develop, and Implement (DMEDI): Ideal for optimizing new processes. Design for Lean Six Sigma (DFLSS): Used, with specialized tools, for customer-driven design of new technologies and services. I facilitate Kaizen events that produced estimated cost of savings of about $400,000/year.

Spirit Airways under contract January 2013 to February 2013

Kinston, NC

Program Manager

Program Management: Working within the Aerospace industry using earned value management (EVM), and Microsoft project systems. Manager - Product Implementation, Project Managers and Program leads. Projects are using composites and aircraft assembly for Airbus 350 products. Production, supply chain, value engineering, cost engineering, quality, Lean, Six-sigma and contracts are the prime areas of focus. Also leading the staffing teams for the programs that are issues and working with Human Resources to resolve them. Clean room: Airbus Specification: AIPS03-02-019 Control Contamination Area Requirements. EN ISO 14644-1, Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanliness. EN ISO 14644- 3, Cleanrooms and Associated Controlled Environments – Part 3: Test Methods. AIMS 12-00-000 Ancillary Materials Type A and Type B. They make use of a 4 square charts: picture, situation, target and proposal. Work to help reduce estimated projected losses of $1,500,000,000 worth of issues for life of the program. Organizational Change Management (OCM). We facilitate Kaizen events: workshops, deep dives, design changes and proposals that yielded a target estimated increase in profits and opportunities of over $1,500,000,000 for the life of the project.

United Technologies Corporation, Corporate Headquarters (Third time) under contract September 2012 to November 2012

Farmington, CT

Commodity Performance Management Specialist

Work on a series of high-level high priority projects. Contract Lifecycle Management Planning, Sourcing Process, Passport (gated review) Process, Factory Executive Leadership Council Planning, Factory Ops Council Planning, Senior Supply Review Board (SSRB) Document and Process Management, Supply Management Analytics, Financial Planning and Analysis, Change Management, New Initiative Planning, Project Management, Communications, Leverage Available IT Solutions, Performance Tracking and Reporting, and Market Feedback Analysis. Organizational Change Management (OCM). Planning and Organizing: structures, staffs and plans work effectively to meet program requirements. Lay out the form of the organization (team structure) which would need to execute the program and identifies the key people for the core team. Involve key players in front end planning (e.g., manufacturing, marketing, suppliers, etc.). Anticipate changes in program requirements over time and adjusts program staffing to meet these requirements. Scopes programs and sets accurate expectations to ensure success. Understands the critical skill and ability requirements of key jobs and matches the right people to these assignments. Communication Skills: expresses ideas effectively to establish self as a credible and capable leader. Actively listens to what others are saying in order to understand situations, issues or problems from their perspective. Communicates with program partners, teams, customers, and senior management on a frequent basis to keep them informed on what is happening with the program. Solicits and considers the input of critical team members before making key decisions. Facilitate communication among key people across project teams and functions within the program. Use simple graphics that capture the essence of a complex system or structure when communicating. Analytical Thinking: takes a systematic and logical approach to analyzing problems. Break down large and complex tasks into manageable tasks and milestones. Ask incisive questions to surface key issues or information needed to make decisions. Insist on objective evaluation of situations by focusing on facts and data rather than subjective feelings and opinions. Clearly identifies the critical path requirements and dependencies at the front end of the program. Drive relentlessly to find root causes. System Thinking: understands the complex interrelationships of the multitude of factors affecting system structure and performance. Identify the most important priorities in the context of all the technical, financial, schedule, organizational, political, people and customer issues that exist at any given time. Able to manage the complexity of details about the program and the people working on it, without getting bogged down in the details. Set priorities on problem solving (e.g., solutions that solve multiple problems) based on understanding the entire system and its interdependencies. Understands how the component projects affect and fit in with each other in a complex program. Stay focused on the broad array of system issues and problems while surfacing and addressing short-term (or most visible) problems/issues. Global General Procurement, Non-Product Commodity Performance: Energy, Plant consumables, Facilities, Office Products, Gas Chemicals. Management Tools: Risk analysis, Strengths, Weaknesses, Opportunities and Threats (SWOT) and Achieving Competitive Excellence (ACE). Target estimated increase in profits and opportunities of over $120,000,000/year.

Boeing Company Second time under contract July 2012 to September 2012

Everett, WA

Project Management and Lean Consultant

Conduct a research and design study for communicating objectives and scope for the 787 Final Assembly program for a consulting group. Perform work force analysis with Human Resources and Industrial Engineering. Conducted surveys with program management: Superintendents, Human Resources management, Industrial Engineering and Lean managers. Experience in project management and strong in workload management. Benchmarking Oobeya rooms: strategy, risk, opportunities, issues and lessons learn within Program Management and Final Assembly Management. Help to mentor many managers, engineers, and others with the teaching of master black belt in lean and 6-sigma techniques with an emphasis on risk management and risk mitigation for assembling aircraft 787 Program. Help development of plans in order to minimize or eliminate potential adverse program impacts. We facilitate Kaizen events that target estimated increase in profits and opportunities of over $300,000,000/year.

Humana Corporation, RightSource under contract August 2011 to February 2012

West Chester, Ohio

Manager, Project Manager

Job Description: Project management: collaborate with internal teams to develop project objectives, business requirements, financial feasibility studies and deliverables. Manager of Product Implementation, Project Managers and Program leads. This is within the Advance Manufacturing Systems group. One of the projects was to create an Over the Counter (OTC) operations mail order factory. I developed a financial supply curve for a supply and demand diagram, for their new Over the Counter (OTC) factory. This helps directs marketing and sales to know where the loss, break-even and profit prices will be and to find the maximum price point to yield the maximum profits. I also developed a feasibility study for the new OTC factory. They were on a course of losing over $4,000,000/year before I presented them with the supply curve and financial

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