| Candidate Information | | Name | Available: Register for Free | | Title | Process Engineer Project Management Quality Assurance | | Target Location | US-KY-Louisville |
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Click here or scroll down to respond to this candidateCandidate's Name
PROFESSIONAL SUMMARYManager 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.SKILLSEngineering ManagementUnion & Non-UnionShopsManufacturing EngineeringRecruiting & HiringBudgetingProject ManagementEquipment Scope. Specification, Design & DevelopmentProcess Design &Development; DOESchedule PlanningFinancial ManagementPriority ManagementTesting & ValidationsAutomationRisk Identification and MitigationDocumentationQualification/ Validation IQ, OQ, PQSix-Sigma Green BeltLean Implementation/ JITKaizen, DMAIC, SWsRequests for Bids/ QuotationsBid Evaluation & SelectionEquipment ProcurementTooling & Fixture Design &ProcurementContract/ Supplier ManagementProcess LayoutPlant LayoutRisk Identification and MitigationcGMP/ ISO Quality AssuranceFMEAs, DOE, SPC, QFDQuality ManagementAuditsAnalytic skillsAdvanced Problem SolvingInformation SynthesisNew Product IntroductionMachine Shop ExperiencePolymerization, various Extrusion, Yarn & Braid Processing, Heat-Treat. Coating, WindingInfluencing & Managing ChangeTeam BuildingMentoringClient & Stakeholder Management3D Modeling CAD: SolidWorks2D CAD: AutoCAD,DraftSightDrawings & BOMMS Office Suite accomplished with Excel, Word, etc.MS ProjectMiniTabKarrass NegotiationKepner-Tregoe Analytic TroubleshootingRoot cause problem solutionsSafetyErgonomicsNFPA, FM, OSHA CompliancePSMP&IDsConceptual DesignCreative IdeationAttention to detailMechanical AptitudeExcellent WriterExcellent CommunicationsTeam PlayerExperienced TrainerMAXIMOPROFESSIONAL SUMMARYQuest Global Engineering, Ltd October 2022 August 2023Senior 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 2021Plant Engineering SupervisorOversaw 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 2015Sr. 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 SLTNS. Inc August 2013-July 2014Designed high speed automation; SolidEdge, AutoCADETHICON, Inc., Div. JOHNSON& JOHNSON, Inc March 1986-September 2005Engineering Section LeaderCoordinated 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 ExperienceMANUFACTURING/PROJECT ENGINEER: DUNLOP SPORTS, Inc, Westminster SC. 8/1981-3/1986Engineering Department. PLC controlled automation and other projects. Rubber ram-extrusion, molding, plastics painting, finishing, inspection, packaging.PROPERTY MANAGER: TWO MAPLES PROPERTIES LLC, Louisville KY 11/2005-9/2012CARROLL COUNTY HIGH SCHOOL Teacher, Engineering and Physics 10/2012-8/2013EDUCATIONBachelor of Science In Mechanical Engineering, Rensselaer Polytechnic Institute. Focus in metals processing.CERTIFICATIONSSix Sigma Greenbelt, Trained in Lean ImplementationProject Management Certificate |
