Statistical Decision & Operations Analyst: Contractor

Resume posted by msuelzer in Scientific.
Desired salary: $60,000.00
Desired position type: Freelance
Location: Hoffman Estates Illinois, United States

michael.suelzer@gmail.com
Tel:
3193338085
Mobile:
3193338085

Summary

An operations analyst and applied statistician providing decision support, predictive modeling, and process engineering services for healthcare, management services, and technology sectors. Has held director-level and Master Black Belt consulting positions in Engineering, Process Excellence, and Quality organizations (ADP Dealer Services, Baxter Healthcare, Boston Scientific, Kinetic Concepts, Motorola, Sprint).
Expertise includes Business Process Optimization, Lean Six Sigma Methods, Quality & Risk Assessments, and FDA and international standards. PMI certified Project Management Professional and an ASQ certified Quality & Reliability Engineer, Quality Manager, and Six Sigma Black Belt. Hold advanced degrees in Applied Mathematics, Statistics, and Experimental Psychology (Human Factors).
Additional information on my background and experience is available on LinkedIn.

Education

Ph.D.  Applied Mathematics          U. of Iowa

MS   Mathematical Statistics      U. of Iowa

MA   Experimental Psychology (Human Factors)  U. of Iowa

AB   Liberal Arts  U. of Notre Dame

 

Experience

Minnetronix Inc.                                                                     Contractor:  Process Engineering                                                                 04/16 – 09/16

Analytics: Data Visualizations & Statistical Methods, Manufacturing Process Capability, Predictive Models,

Workflow Mappings & Models, Test Method Validation

Consults:    FDA (CFR Part 820) Regulations & ISO (13485, 14971, 15288) Guidelines,

Lean Six Sigma Process Engineering, Systems Engineering (INCOSE Handbook 4th ed.)

Product:   Ventricular Assist Device (VAD) Controller

Boston Scientific                                                                                  Contractor:  Statistical & Operations Analytics                09/15 – 04/16

American Medical Systems                                                                                                                                                                                                                                          09/14 – 09/15

Analytics:   Data Visualizations & Statistical Methods, Decision Optimization, Design of Experiments, Manufacturing Process Capability, Test Method Validation, Workflow Mappings & Models

Consults:    CAPA Investigations, Data Science, FDA Regulations & ISO Guidelines, and

Lean Six Sigma Process Engineering

Products: Hydraulic Urinary Sphincter & Penile Prostheses

ADP Dealer Services (CDK)               LSS Master Black Belt (MBB)         Contractor                                         10/12 – 08/14

Analytics:   Business Process Capability, Data Visualizations & Statistical Methods, Decision Optimization, Measurement Systems Assessment, Predictive Models, Workflow & Value-Stream Mapping

Consults:    Business Process Modeling, Data Science, Design for Six Sigma (DFSS),

Lean Six Sigma Process Engineering, and Systems Engineering

Services:               Vehicle Sales & Service Transactions

Kinetic Concepts (Acelity)                              Director, Process Excellence; LSS MBB                                         06/11 – 04/12

Analytics:   Data Visualizations & Statistical Methods, Decision Optimization, Design of Experiments, Manufacturing Process Capability, Measurement Systems Assessment, Predictive Models,

Consults:    Business Process Models, CAPA Investigations, Data Science, Design for Six Sigma,

FDA Regulations, and Lean Six Sigma Process Engineering

Products: Negative Pressure Pump, Wound Healing Laminates

Baxter Healthcare                                                                    Technical Director, Engineering; DFSS MBB                    02/07 – 06/11

  • Provided Predictive Analyses and Validation Tests for CAPAs & FDA Consent Decree Remediations
  • Researched & drafted Risk Management Process: Mapped process workflows, lead Kaizen events, & produced

validation procedures complying with ISO (13485, 14971, & 15288), ICH Q9 & FDA regulations (CFR Part 820)

  • Constructed Discrete Event Simulation Models:

Material Qualification Process — Eliminated choke point reducing yearly study time by 400 hours & $200K

Software Buffer — Determined buffer size reducing false alarms of infusion pump under consent decree

  • Developed & Delivered DFSS & Statistical Training Modules to 75+ engineers; Coached 8 DFSS projects
  • Researched & Developed Logistics & Inventory Models for Operating Room of the Future Project

 

Motorola                                                                                                           DFSS Instructor, MBB Consultant                                                              11/06 – 02/07

Distinguished Member of Technical Staff                                           09/04 – 11/06

Principal Staff Scientist, Quality Manager                              06/00 – 09/04             

  • Program Managed Software DFSS Curriculum: Initial CMMI compatible modules finished in 6 months
  • Led Optimization Teams & Project Managed Six Sigma (DMAIC) Process Improvement Projects:

Maintenance of Line System:  $16.8M Profit Increase;                 Software System Testing:         $7.8M Cost Savings

  • Developed systems & reliability analyses, operations research & predictive modeling services, multivariate statistical methods, and software tools to automate analyses & optimize reliability growth & cost of quality
  • Created & Simulated Discrete Event (DES) Workflow Models to Simplify Configuration Management Processes
  • Managed Software Release Readiness Review Team: Continuously improved process for 34 worldwide sites

Sprint                                                                                        Contractor:    Senior Consultant Metrics                                       10/98 – 01/00

Quality Manager                                                                                                                                              07/96 – 10/98

  • Designed and Managed:                                     Decision Support System for Sprint-Cisco-Tellabs team of 149 engineers

developing Voice-over-ATM switch within 18 months and $10M budget;

UNIX defect-tracking & critical parameters reporting system

  • Researched QA Best Practices:             Managed Gartner account for CIO and VP of Strategic Planning
  • Led Quality Engineering Group: Designed software development framework & risk assessment procedures

Colgate Palmolive                                                                    Senior Statistician                                                                                                                               10/93 – 07/96

  • Provided FDA liaison, GMP/GLP guidance, and Statistical Consulting & Analyses for Hills Pet Nutrition
  • Supervised Research Information Services Group providing decision support for Prescription Diet® research
  • Analyzed requirements for Oracle-SAS Laboratory Information Management System (LIMS)
  • Constructed statistical argument convincing FDA to shorten a research protocol & save $10-20K per study

 

Skills

  • 20+ years experience:
  • Analytics: Data Visualizations & Statistical Methods, Decision Optimization, Design of Experiments,
  • Business & Manufacturing Process Capability, Measurement Systems Assessment,
  • Predictive Modeling, Process Workflow Mappings & Models, Test Method Validation
  • Consults: Business Process Modeling (BPM), CAPA Investigations, Data Science, Design for Six Sigma
  • (DFSS), FDA (CFR Part 820) Regulations, ISO (9001, 13485, 14971, 15288) Guidelines,
  • Lean Six Sigma Process Engineering, and Systems Engineering (INCOSE Handbook 4th ed.)
  • PMP, CQE, CRE, CQM/OE, CSSBB

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