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Sr. Level Process Engineer Resume Example

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SR. LEVEL PROCESS ENGINEER
Summary
  • Lean Six Sigma Certified Black Belt Engineer seeking an Engineering position as Sr. Level Process Engineer or Continuous Improvement Engineer. SUMMARY OF QUALIFICATIONS:
  • Fifteen years plus of expansive background & experience in various Manufacturing, Quality Engineering, Production Planning, Product Design & Development, and Engineering Management in Medical Device, Laser Printing and Automotive Industry.
  • Strong background in statistics and excellent skills in Quality Planning tools, System Design, Multivariate Statistical Analysis, Time Series Analysis, Statistical Process Control (SPC), Quality Management Systems (QMS), Design for Manufacturing (DFM), Design for Assembly (DFA), Lean Manufacturing, Advance Product Quality Planning (APQP), PPAP, Failure Modes & Effects Analysis (FMEA), Design Verification Plan & Report (DVP&R), Gage R&R, 8DTechniques, Benchmarking, Kaizen, Fishbone Diagram and Material Requirement Planning (MRP).
  • Compliance with following Regulations Standards: 21CFR820, ISO 9000, CE Mark, MDD, UL, IPC, and ISO 13485.
Skills
  • Lean Six Sigma Project Tools, PDM Software, AutoCAD, Minitab19
  • Auditing, Quality
  • Cleaning validation, IQ, OQ, PQ
  • Continuous improvement, Risk Analysis
  • Data collection, Risk Assessment
  • GMP, Safety
  • SPC, Wonderware
  • ISO, Statistical process control
  • Supply Chain Management
  • Six Sigma Team Coaching & Training
  • Project Management
  • Poke Yoke Method and Product & Process FMEA & Control Plans
Experience
Danaher CorporationMarch 2012 to CurrentSr. Level Process Engineer
Pensacola, Florida
  • Led multiple six sigma projects that substantially improved production through-put by elimination of nonvalue added work and establishing critical KPI control plans which reduced finished goods scrap by $1.5 million annually.
  • Acted as manufacturing liaison in new media product introduction to manufacturing, through establishing new equipment introduction and carrying out initial testing and product introduction to to the value stream.
  • Slashed external customer defects by 99% by leading to completion, media inspection vision systems completes installation and qualification project that resulted improved media quality with $3 million annual savings of COPQ.
  • Streamlined media failures and rework due to endotoxin/bioburden failures by successful introduction of new cleaning/sanitizing validation with 2 million net annual savings.
  • Optimized die changeover utilizing SMED methodology which resulted in reducing change over time from 45 minutes to 10 minutes with 1 million annual savings.
  • Reduced response time to external customer complaints to resolution to 4.5 days by utilizing lean six sigma tools.
  • Led Project to install two-tier SPC Module system for critical X and Y Variables to improve detection and response time within virus media value stream.
Smith & Nephew Wound ManagementDecember 2007 to January 2010Sr. Level Process-Improvements Engineer
Largo, Florida
  • 3Million Annual Savings).
  • Led projects to eliminate waste from Wound Management value stream by using value stream mapping to improve quality KPI by implementing control plans and poke yoke measures.
  • Carried out to completion CAPA Projects.
  • Led lean six sigma training module to teach engineering staff how to utilize 6-Sigma methodology (DMAIC), data collection techniques & analysis using SPC Software packages such as Minitab and Quality Companion Project Management Software in real time execution of black belt projects.
  • Managed new equipment installation initiatives, Interfaced with vendors to improve process Equipment, new tooling and fixtures needed for new product launches.
  • Work closely with Production Floor to identify areas that need improvements and waste elimination using Lean Six-Sigma tools such as DOE, Value Stream Mapping, FMEA, Fishbone Diagrams and process and product Reliability and Quality enhancements tools.
  • Performed retrospective and prospective Process and product Validation and Verification Projects including IQ, OQ, PQ and PPQ activities in accordance to Master Validation Plan and Risk Assessment Quality System.
  • Equipment Utilization Enhancement Projects such as 5 S, Change-over reduction SMED method and Mistake Proofing with yield of more than $300K annually.
  • Worked very closely with internal customers to provide technical support for Safety, Purchasing for new vendor qualification.
  • Conducted Gage R&R studies, GNG Gauge as needed.
Strategy Engineering Consulting, Dental & Medical Devices, Implantable Dental DevicesJanuary 2000 to January 2007Process Improvements Manager / Consultant Engineer
Clearwater, Fl
  • Led consulting engineering large project to optimize dental lab throughput efficiency by utilizinglean combined with six sigma tools to eliminate Non-Value added work, improve flow to reduce lead time for crown mold creation from 3 days to 6 hours with annual savings of $500,000.
  • Spearheaded monthly data reviews to identify production issues and developed resolution plan.
  • Led manufacturing team in conducting root cause analysis, and assisted in developing corrective action for defects related to manufacturing process.
  • Supported internal & external assessments, complaint investigations, recalls, CAPA, design and management review.
  • Performed Hazard Analysis, and Robustness Design Methods.
  • Conducted change control to form, fit or function using process verification and validation to ensure compliance of product manufacturing to FDA regulations.
Education and Training
Texas A & M UniversityMay 1987Bachelor of Science: Mechanical Engineering With Minor in Quality Eng
Florida Institute of Technology-MelbourneJanuary 2020Florida Institute of Technology Lean Six Sigma Certified Black Belt Certificate Number: FT202022: Lean Six Sigma Black Belt CertificationMelbourne, FL
Additional Information
  • PERSONAL: , U.S. Citizen, Bilingual. Recently been accepted in the Master Program in Biomedical Engineering
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Resume Overview

Companies Worked For:

  • Danaher Corporation
  • Smith & Nephew Wound Management
  • Strategy Engineering Consulting, Dental & Medical Devices, Implantable Dental Devices

School Attended

  • Texas A & M University
  • Florida Institute of Technology-Melbourne

Job Titles Held:

  • Sr. Level Process Engineer
  • Sr. Level Process-Improvements Engineer
  • Process Improvements Manager / Consultant Engineer

Degrees

  • Bachelor of Science : Mechanical Engineering With Minor in Quality Eng
    Florida Institute of Technology Lean Six Sigma Certified Black Belt Certificate Number: FT202022 : Lean Six Sigma Black Belt Certification

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