Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Michael McDaniel

Rockledge

Summary

Dynamic professional seeking a permanent full-time opportunity with an organization dedicated to enhancing processes, quality, and overall profitability. Proven track record of driving improvements and implementing effective strategies that contribute to organizational success. Authorized to work in the U.S. for any employer, offering a strong work ethic and results-oriented mindset for every project. Eager to leverage skills and experience in a collaborative environment that values innovation and continuous improvement.

Overview

29
29
years of professional experience
1
1
Certification

Work History

Manufacturing Engineering Manager

Piper Aircraft Inc
10.2024 - Current
  • Lead and manage team of Manufacturing Engineers in the production of light aircraft.
  • Troubleshoot manufacturing problems
  • Conduct cost take out efforts
  • Improve rolled throughput yield
  • Reduce scrap
  • Implement new processes and equipment selections
  • Conduct Six Sigma Training
  • As the only on-site Six Sigma Master Blackbelt I am conducting all in house Six Sigma methodology training.
  • Led projects netting over $1M savings for the year.

Independent Contractor

Various Contract Positions
05.2022 - 10.2024
  • Six Sigma Black Belt for continual improvement efforts, Kaizen events, daily GEMBA activities for manufacturing and healthcare efforts.
  • Implementation of ISO Based Quality Management Systems, FDA, GLP and GMP systems.
  • Directly responsible for all Medical Device Products and customers.
  • Management experience in ISO 9000. AS 9100, ISO 13485, TS 16949, ISO 14001 and AS 13001.
  • Initiate and oversee new product launches.
  • Lead Material Review Board efforts.
  • Review and approve First Article Inspections for level 1-2 QE's
  • Initiate supplier contact and RMA Requests for Supplier Issues and conduct Supplier Audits as needed.
  • Lead Internal Quality Management System Audits and act as Company Representative in 3rd party Audits.
  • Assign Six Sigma projects and conduct Six Sigma training.
  • Customer Liaison for quality issues as they arise.
  • Certified IPC Specialist IPC-A-610

Founder/Chief Executive Officer

Infinity Medical Engineering
05.2011 - 12.2022
  • Invented unique Urologic medical device that works in conjunction with the Foley style indwelling catheter.
  • Started Infinity Medical Engineering as founding member, focusing on Class 2 medical devices. Making large IP sale in a 12-year period.
  • Director of Quality duties - Implement ISO 13485 Quality Management System and complete certification. Authored all quality SOP's, Work Instructions and Quality Forms, Oversee and approve design freeze, validations and IQ, OQ, PQ efforts and FDA Communications/Submissions. Internal Audits to ISO 13485, ISO15223, ISO 20417 and ISO 16142
  • Responsible for capital fund raising and investor relations.
  • Responsible for all project and budget timelines for company and all existing projects.
  • Continual improvement of processes and products from design/development through manufacturing and FDA submissions.
  • CO-developed unique co-monomer QUAT Antimicrobial which mixes with common polymers, making material antimicrobial to a 6-log reduction within 2 minutes.
  • Developed and produced breaking ground technology with the world’s first antimicrobial Urinary Catheter.
  • Make presentations for regulatory compliance strategies and final FDA submission presentations to the FDA.
  • Develop Board of Directors, business plan and overall company strategy and direction.
  • Developed anti-fouling coatings for several industrial markets using our unique antimicrobial technology.

Sr. Supplier Quality Engineer

General Electric
10.2008 - 04.2011
  • Directly responsible for all Asian based suppliers to GE Appliance, Aerospace, Energy (Steam and Gas Turbine) and Medical.
  • Conduct supplier quality audits, selections, and final negotiations with procurement leaders.
  • Responsible for oversight on all CAPA investigations on tier 1 non-conformities (safety and human life related)
  • Responsible for MCTO (Material Cost Take Out) projects for Asian supply chain. Netting $1.2 million savings on a single project.
  • Restructured GE Business Survey and Supplier Quality Audit format resulting in a better audit structure for GE Corporate, as well as revise and improve ISO based systems, conduct internal FDA, REACH, RoHS regulatory compliance audits and acted as management representative if needed. documents and procedures.
  • Developed call center metrics for customer complaint autopsy process for field failures and complaints on Asian supplied components.
  • NPI (New Product Introduction) validation on GEA Vertical Washing Machine and Bottom Out Freezer integrated Hardware and Software applications for 2012 released products.

Principal/Lead Consultant

Southern Indiana Quality Consultants
09.1996 - 10.2008
  • Lead L6S project and conducted validation activities (IQ, OQ, PQ) for Stryker Medical. Launched 6 new product projects in a 12-month period. Also validated powder coat and stripping line and led L6S project to reduce cost and increase product throughput yield with over $600K bottom line improvement to company (Completed validation projects on software, hardware, processes and product concentrated on medical device applications).
  • Lead L6S Continuous Improvement project for e-coat and Powder Metal lines through capital acquisitions, line layouts and team training (L6S) for metal finishing as contractor for GE Medical and Appliance.
  • Conducted all FDA, GMP compliance internal audits and acted as contract management representative for FDA, GMP and ISO 3rd party Audits for Stryker Medical (MI), Boston Scientific (IN) and Medetech (MA).
  • Developed supplier quality systems and internal quality improvement processes for MedVenture Technologies (Medical Device Development and manufacture) Acted as quality liaison to Boston Scientific, Johnson and Johnson, Covidien and Svelte Technologies. Acted as FDA Audit Guide.
  • Implemented, and developed ISO 9000 and AS9100 Quality Assurance Systems for companies in the Louisville Kentucky area such as Precision Elamex, Accu-tec, Plastech, Jones Plastics, Rev-A-Shelf, VG Reed and Sons, Aisin Drivetrain, Samtec, Inc., PK Industries.
  • Acting Plant Manager for 9 months at Electrolux in Columbia South Carolina to reduce waste, improve quality, reconfigure production flow and increase profitability. Resulted in MCTO Savings of $1.1M, RTY improvements of $96K (Monthly) and DPPM decrease from23,000 to
  • Obtained TS 16949, AS 9100 and ISO 14001 certifications for Samtec in 4-month period. Resulting in a $160,000.00 budget savings for company.
  • Several Capital Machine Acquisition and set up projects for GEA and GEM. Developed Statistical Preventive and Predictive maintenance for both divisions using 6S methodologies.
  • Lead ISO13485 Systems improvements and conducted internal audits for Boston Scientific (Spencer, Indiana facility) as well as L6S and 5S activities. Opened over 3200 sq ft for new production through 5S activities and decreased internal PPM from >2400 to
  • Implementing ISO/TS 16949 QMS transition from QS 9000 and conducting all internal audits for TS process as well as TS toll out training. (Aisin Drivetrain, Crothersville, IN and Samtec, Inc, New Albany, IN) AS9100 standards (electrical) review and audits.
  • Lead Lean Six Sigma project for Six Flags Kentucky Kingdom resulting in $600K savings and lean process improvements. Conducted training for Green Belts for SFKK Departmental Managers.
  • Lead Six Sigma Project for Lockheed Martin Corporation in King of Prussia, PA. (Certified Six Sigma Black Belt Project Manager)
  • Principal sub-contract consultant for Environmental Management Solutions and Management Solutions inc. (Indianapolis, Indiana 2006-2008)
  • Freelance Quality Systems/Continuous Improvement
  • Various Companies

Education

Business Administration/Quality Management Emphasis (B.S.) -

Trinity College
Chicago, IL
05.2000

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GE Corporate Training Center
New York, NY
11.1998

Applied Science (Associate) - undefined

IVY Tech State College
Terre Haute, IN
06.1993

Skills

  • Mentoring
  • APQP
  • Marketing
  • Welding
  • Product demos
  • Organizational skills
  • Contracts
  • Leadership
  • Six Sigma Black Belt certification
  • Quality audits
  • Non-destructive testing
  • Risk management
  • Manufacturing engineering (10 years)
  • Root cause analysis
  • FDA regulations
  • Product management
  • Six Sigma
  • Continuous improvement
  • Data analysis skills
  • ISO 9001
  • Minitab
  • Auditing
  • Assembly
  • ERP systems
  • Manufacturing
  • Supervising experience
  • Quality assurance
  • Visio
  • Communication skills
  • Blueprint reading
  • PPAP
  • Lean Six Sigma
  • Lean
  • Quality systems
  • Project implementation
  • IPC 610 (10 years)

Certification

  • Six Sigma Master Black Belt
  • Present
  • Trainer and educator of Lean Six Sigma methodologies and leader in Six Sigma projects netting a career savings of over $12 B
  • Lean Six Sigma Master Black Belt
  • Lean Six Sigma Certification
  • Certified Quality Auditor
  • Six Sigma Black Belt
  • Certified Quality Engineer
  • Driver's License
  • Lean Six Sigma Green Belt
  • Six Sigma Green Belt
  • Six Sigma Certification

Timeline

Manufacturing Engineering Manager

Piper Aircraft Inc
10.2024 - Current

Independent Contractor

Various Contract Positions
05.2022 - 10.2024

Founder/Chief Executive Officer

Infinity Medical Engineering
05.2011 - 12.2022

Sr. Supplier Quality Engineer

General Electric
10.2008 - 04.2011

Principal/Lead Consultant

Southern Indiana Quality Consultants
09.1996 - 10.2008

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GE Corporate Training Center

Applied Science (Associate) - undefined

IVY Tech State College

Business Administration/Quality Management Emphasis (B.S.) -

Trinity College

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