Experience

• 

  Nephron Pharmaceuticals

  • West Columbia, South Carolina, United States

  • Consultant

    • Nov 2023 - Dec 2023
    • West Columbia, South Carolina, United States

    Short-term assignment.• Scope consisted of compiling holistic list of engineering and technical projects then determine resource allocations and skill matrix required to support. • The workload encompassed investigation / responses to FDA 483 observations and warning letters, validation of new b...

• 

  BD

  • United States
  • Medical Equipment Manufacturing
  • 700 & Above Employee

  • Director of Manufacturing Engineering

    • Oct 2017 - Oct 2023

    • Leader for manufacturing technology development and implementation across two business segments consisting of 12 manufacturing locations worldwide. • Championed process development to support new product launch, Quality improvements and cost reductions of medical devices and diagnostic consumables. • Provide feedback on Total Cost of Ownership and Design for Manufacturability to Core teams utilizing Six Sigma tools (Design of Experiments, Capability Studies, etc.). • Facilitator of process standardization and project management standardization efforts.• Responsible for engineering management succession planning and development.• Direct reports consisted of 4 engineering groups (25 total). Indirect responsibility for technical team located in manufacturing facilities. • Managed average yearly CapEx budget of $30 million.Processes: High volume assembly, custom automation, spray atomization, liquid dispense, vision inspection, ultrasonic welding, UV curing, packaging, robotics, pick-n-place, vibratory feeding, surface treatment, heat seal, form fill seal, automated material handling, label application, rubber mixing/pelletizing/compression molding, sterilization (Cobalt, EtO, Autoclave).

  • Senior Manager, Operations Central Engineering Group

    • Feb 2014 - Oct 2017

    • Cross functional leader for launching major capacity expansions in Brazil and China. • Work closely with cross functional teams (R&D, Medical Affairs, Regulatory, Quality) to sustain product life cycle. Scope included material changes, CAPA’s, ISO/FDA compliance, etc. • Team consisted of Injection Molding engineers (4), Assembly engineers (6), Materials Scientist (1), Packaging engineer and technician (3) and Rubber Technologist (1).

  • Interim Engineering Manager

    • Sep 2014 - Feb 2015

    Technical leader in supporting plant turnaround. Increased productivity 25% through focus on downtime reductions, waste reductions and hiring key technical positions.

  • Engineering Manager – Tubes / Sterilization / Rubber

    • Jan 2009 - Sep 2014

    • Responsible for leading team in development, implementation, and validation of highly complex, custom-built automated assembly lines used for high volume manufacturing.• Led staff of 21 (7 engineers, 14 technicians). The department consisted of approximately 250 associates in total. Owner of technical team talent development. • Shared responsibility for department financial metrics. • Teams responsible for IQ, OQ, PQ protocols and compliance with FDA and GMP regulations. • Utilized LEAN techniques to implement $2,800,000+ annualized cost reductions.

  • Maintenance Manager

    • Aug 2007 - Jan 2009

    • Responsible for Preventive Maintenance (PM) budget and completion compliance.• Led optimization efforts on Predictive Maintenance (TPM) along with.• Owner of expense labor budget ($500,000) and spare parts inventory ($1,000,000).• The group consisted of 42 technicians and machinists.

  • Engineering Manager – Straight Needles

    • Apr 2004 - Aug 2007

    • Responsible for leading team in development, implementation, and validation of highly complex, custom-built automated assembly lines used for high volume manufacturing.• Led staff of 16 (4 engineers, 12 technicians). The department consisted of approximately 100 associates in total. Owner of technical team talent development. • Shared responsibility for department financial metrics. • Teams responsible for IQ, OQ, PQ protocols and compliance with FDA and GMP regulations• Led implementation of $2,150,000+ annualized cost reductions over 3-year period.

  • Project Engineer

    • Oct 2001 - Apr 2004

    • Implemented lubrications system that processes a flammable solvent (Soltrol). Subject Matter Expert and trainer for “handling flammable materials”.

• 

  Siemens

  • Johnson City, Tennessee Area

  • Engineering Supervisor - Project Management Group

    • Jan 1999 - Oct 2001
    • Johnson City, Tennessee Area

    • Work directly engineering group in Regensburg, German on design, build, installation and production support of custom assembly equipment to manufacture and test airbag control modules. • Plant lead for development and launch of 4 new control modules.• Core team member that worked directly with...

• 

  THOMAS AND BETTS CORPORATION

  • Spartanburg, SC

  • Sr Manufacturing Engineer

    • Feb 1993 - Jan 1999
    • Spartanburg, SC

    • Worked directly with customers (GM, Chrysler, Ford, Dell, IBM, Ericsson) on design, development, and production launch of new connector systems.• Quoted new connector system product costs directly to Marketing. Worked with Finance and Operations groups to perform payback analysis. • Designed b...

• 

  Burns Aerospace

  • Winston-Salem, NC

  • Product Design Engineer

    • Dec 1991 - Feb 1993
    • Winston-Salem, NC

    • Created solid models in PROENGINEER to perform kinematic analysis and tolerance stack-up studies on passenger airline seating. • Lead Designer under armrest air phone in joint venture with GTE. Processes: Machining, Tube bending / cutting, assembly, vacuum forming, welding