KEITH LABRECQUE

PROFESSIONAL SUMMARY

Manager of Manufacturing, Process & Design Engineering with varied experience in Medical Device manufacturing (cGMP environment); also, Consumer Product and Industrial Equipment industries. Strong knowledge and experience in leading and performing investigating/ designing/ redesigning and optimizing procedures, products, processes, equipment, controls and automation for reliability of product, delivering significant cost savings and quality improvements while enhancing compliance to regulatory requirements. Ability to develop and implement feasible timelines and budgets. and effectively lead cross-functional multi-disciplinary teams through strategic leadership and outstanding problem-solving skills. Excellent business communication, organizational and interpersonal skills, with the capacity to increase productivity and profit margins in a fast-paced, dynamic business environment. Self-directed, with an excellent ability to make critical decisions in a timely manner, without complete information and under tight deadlines and pressures.

SKILLS

Engineering Management

Union & Non-Union

Shops

Manufacturing Engineering

Recruiting & Hiring

Budgeting

Project Management

Equipment Scope. Specification, Design & Development

Process Design &

Development; DOE

Schedule Planning

Financial Management

Priority Management

Testing & Validations

Automation

Risk Identification and Mitigation

Documentation

Qualification/ Validation IQ, OQ, PQ

Six-Sigma Green Belt

Lean Implementation/ JIT

Kaizen, DMAIC, SWs

Requests for Bids/ Quotations

Bid Evaluation & Selection

Equipment Procurement

Tooling & Fixture Design &

Procurement

Contract/ Supplier Management

Process Layout

Plant Layout

Risk Identification and Mitigation

cGMP/ ISO Quality Assurance

FMEAs, DOE, SPC, QFD

Quality Management

Audits

Analytic skills

Advanced Problem Solving

Information Synthesis

New Product Introduction

Machine Shop Experience

Polymerization, various Extrusion, Yarn & Braid Processing, Heat-Treat. Coating, Winding

Influencing & Managing Change

Team Building

Mentoring

Client & Stakeholder Management

3D Modeling CAD: SolidWorks

2D CAD: AutoCAD,

DraftSight

Drawings & BOM

MS Office Suite – accomplished with Excel, Word, etc.

MS Project

MiniTab

Karrass Negotiation

Kepner-Tregoe Analytic Troubleshooting

Root cause problem solutions

Safety

Ergonomics

NFPA, FM, OSHA Compliance

PSM

P&IDs

Conceptual Design

Creative Ideation

Attention to detail

Mechanical Aptitude

Excellent Writer

Excellent Communications

Team Player

Experienced Trainer

MAXIMO

PROFESSIONAL SUMMARY

Quest Global Engineering, Ltd October 2022 – August 2023

Senior Lead Manufacturing Engineer [Contract]

Performed a detailed Process Failure Mode and Effects Analysis (pFEMA) on a 36-step inline process.

Designed on AutoCAD an upgraded capacity 400 psi nitrogen Purge System with improved reliability and safety; piping with P&ID.

Completed build-out of a process QA Lab.

Designed an automated moveable process guide to prevent catenary strips from dragging (AutoCAD).

UPS. Inc March 2016 – September 2021

Plant Engineering Supervisor

Oversaw monitoring, analysis and improvement to operational reliability of tens of thousands of units of package handling and sorting equipment, using infrared scanning and other approaches.

Led teams of 30-year veteran union employees.

Have been recognized for having a superior performing team – ‘’best results at WorldPort” by Wing Manager Well-loved by teams (campaigned to delay my progression).

MEDVENTURE TECHNOLOGY CORP February 2015-August 2015

Sr. Process Engineer [Contract]

Coordinated the process development of braiding assembly of medical devices (surgical catheters) in a cGMP environment.

Responsibilities included: process design, analysis, troubleshooting, process development and improvement, and procurement, Design of Experiments, validation in cGMP & clean-room environment.

Liaise with product engineers and clients to streamline and optimize processes through insightful troubleshooting operational oversight and strategic leadership.

Achieved client objectives, including optimizing a failing production process and eliminating costly and unnecessary processes through creative troubleshooting.

Identified root causes of failures, thereby improved key process uptime 360x between failures, besting the design cycle time for manufacturing lots.

Partnered with all levels of management and client teams to drive consensus, collaboration and forward momentum toward the timely completion of project milestones and the attainment of client goals.

SR. MACHINE ENGINEER: FARHEAP SLT’NS. Inc August 2013-July 2014

Designed high speed automation; SolidEdge, AutoCAD

ETHICON, Inc., Div. JOHNSON& JOHNSON, Inc March 1986-September 2005

Engineering Section Leader

Coordinated and oversaw implantable medical devices manufacturing development operations implementations.

Responsible for project liaison, with teams and vendors located in Germany, Puerto Rico, Texas, New Mexico, and New Jersey.

Held bottom line responsibility for multi-million-dollar budgets and managed the activities of a variety of teams of 6 to 15 cross-functional areas and 8 direct reports (Engineers. Designers. Co-Ops and Technicians). AutoCAD.

Lead teams as an active member, spearheading multiple projects for a series of process and equipment solutions resulting in a quantum leap in robustness of the manufacturing process to quickly reverse the production of failed products: saved $10M.

Increased measured key parameters (averages) across the flagship product line by 35% up to as much as 70%, resulting in extraordinary market advantage vs. prior market disadvantage, leading to:

Market penetration increased by $60M/year as a result of the new competitive performance advantage.

Led other major upgrades of flagship product via product and process redesigns (redesigned coating to eliminate carcinogenic solvent and added anti-microbial particulate to coating) for further $50M annual market penetration (VlCRYL• PLUS). Patented.

Led Corporate-wide $1.2M Capex new process & equipment project which incorporated major environmental improvements (removed carcinogens: creatively designed compliant explosion-proof equipment for use in ordinary-hazard area): increased speed of bottleneck process by 500% while greatly reducing quality defects. Multiple patents. $1.2M Capex Project. PSM with P&ID. AutoCAD.

Consistently exceeded goals driving process, cost, quality, and capacity improvements, including process optimization, problem solving and debugging, and achieved additional cumulative cost avoidances of over $650k.

Designed and led quantum-improved polymer process reactor/ pelletizer system which improved troublesome key polymer parameter by 15%. $1.6Mcapex project. PSM with piping, P&ID. AutoCAD.

Introduced Spin-Draw Extrusion as a new technology; gained 100% in speed with the operators.

On Lean Implementation Core Team; delivered 33% labor savings (15 of 45 operators) and collapsed six process steps into three.

Delivered innovative new technologies and expanded capacities 325%.

Eliminated several carcinogenic process materials – 17 tons/year.

Saved 21% of city water usage at $41k/year and reduced other costs by an additional $77k each year on average, without compromising quality.

Numerous other impactful projects and accomplishments.

Additional Experience

MANUFACTURING/PROJECT ENGINEER: DUNLOP SPORTS, Inc, Westminster SC. 8/1981-3/1986

Engineering Department. PLC controlled automation and other projects. Rubber ram-extrusion, molding, plastics painting, finishing, inspection, packaging.

PROPERTY MANAGER: TWO MAPLES PROPERTIES LLC, Louisville KY 11/2005-9/2012

CARROLL COUNTY HIGH SCHOOL Teacher, Engineering and Physics 10/2012-8/2013

EDUCATION

Bachelor of Science In Mechanical Engineering, Rensselaer Polytechnic Institute. Focus in metals processing.

CERTIFICATIONS

Six Sigma Greenbelt, Trained in Lean Implementation

Project Management Certificate

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