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Tech Transfer Based Medical

Location:
Exton, PA
Posted:
January 01, 2024

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Resume:

PROFESSIONAL HIGHLIGHTS

●Validation and process characterization of two step polyurethane synthesis-tech transfer and scale up

●Optimized mixing process to improve dispersion of TAIC, Irganox, and Kynar 3000 processing aid in PE formulations resulting in 45% yield improvement of medical tubing at end of line.

●Validation of Dynamic Mechanical Analyzer to predict appropriate degree of crosslinking in PE based medical tubing

●Rubber compounding to improveextrusion of thin sidewall for tear strength,green strength,and product/processing properties

●Evaluated instrument suppliers for support and justified capex purchase of Karl Fisher.Evaluated instrument suppliers for support and justified capex purchase of Mettler Toledo Karl Fisher Titration instrument to test polyol for polyurethane foam. Set up lab procedures and test. Used titration KF instrument to test polyol for polyurethane foam. Set up lab procedures and test.

●Evaluated instrument suppliers for support and justified capex purchase of TA Instruments DMA to determine effect of e-beam induced crosslinking in HDPE medical tubing

●Process improvement and monitoring using FTIR for reactive twin screw Thermoplastic Polyurethane synthesis

●Improved FTIR analysis technique of compounded PE based resin pellets using transmission mode and specially designed cell

●Specification development for OEM customers and improved new products introduction-GD&T and critical process specifications

●Excellent MS Office, Minitab 19, customer presentation, specification development, 6 Sigma, Lean MFG, and DOE skills

●Performed hypothesis testing with Minitab to determine defect level was statistically improved

●Applied SPC and process capability statistics to guide the need for process or formulation improvements

●Supervised quality control lab technician to run experiments and tests to determine if improvements statistically improved process

●Intellectual property engineering creating patent clusters and developing value presentations. Patent disclosure development

●Extensive Work instructions writing to improve clarity and eliminate process errors. Included pictures and diagrams

●FTIR utilization to improve process performance. Skilled in Rheological, mechanical and astm testing of rubber.

●Skilled in material selection, formulation to improve downstream processing, NPI, product attributes, reliability, and cost

●Application engineering presenting reliability performance and checkpoints, product delivery and thermal/material modeling

●Performed root cause analysis to determine reason for rubber off-batches to prevent re-occurrence

●Single Screw rubber extrusion of as fluorinated thermoplastic resins PVDF, PE, neoprene, Butyl and isoprene

●Root cause analysis of cracking of medical tubing during expansion as a function of e-beam dose

MATERIAL EXPERIENCE

Polymers: numerous polyimides,thermoplastic polyimide: Ultem, polyimide siloxane, polyarylbenzimidizole, Kevlar, silk, polyvinyl alcohol, polyvinylidene fluoride, polyethylene, thermoplastic polyurethane, polyurethane foam, nylon fabric, polyester fabric, polydimehtyl siloxane, FEP, and pvc.

Rubber: SBR, chlorobutyl. bromobutyl, polybutadiene, polyisoprene, natural rubber, and polyimide siloxane

PROFESSIONAL EXPERIENCE

TE connectivity Medical – Staff Material Scientist,remote in Exton PAfor Wilsonville, OR on site inR&D HQ Middletown, PA Exton, PA

April 2021 – June 2023

●Extruded pure polyethylene tubing to assure proper doses of e-beam via measurement of transvinylene absortion band in FTIR

●Validated DMA for use inline to assess crosslink density as a result of E-Beam. Correlated results to post expansion dimensions

●Used DMA to assess storage modulus of thin tubes treated as fibers for purpose of predicting crosslink density

●Established finished outgoing Material Formula and Testing specification documented in the COA for thermoplastic polymeric compounds mixed by outside compounder via twin screw.

●Improved PVDF extrusion by eliminating melt fracture defects by applying a DOE resulting in increasing Extrusion temperature

●Monitored post twin screw extrusion compounding using FTIR to ensure adequate crosslinking additive concentration

●Failure analysis of end of production line defects directed to medical tube cracking and low tensile strength.Investigated using FTIR, DSC, TGA-MS and Minitab statistical software.

●Investigated extrusion hardware composed of Nickle-Titanium alloyed metal surface coated with fluoropolymerfor post cleaning residue via EDX -SEM.

●Used MS Project to detail Validation and Compounding improvement projects improving yield by 45% and allowing high revenue medical 1.0mm PE tube to be shipped. Implemented re-extrusionpost twin screw compounding to realize yield

Royal DSM Biomedical – Thermoplastic Polyurethane Process Engineer, Exton, PA

April 2020 – Dec 2020 Contract via Manpower Prof. Div.

●Performed IQ, OQ, and POQ process and equipment validations directed to two-step process to synthesize thermoplastic polyurethanes via reaction vessel and twin screw extrusion for biomedical applications.

●Monitored pre-polymer reaction using FTIR to ensure dimer and urea side reactions were not occurring. Monitored isocyanate peak in finished resins post twin screw reaction extrusion using FTIR.

●Failure analysis of customer field returns with associated corrective actions.

●Packaging design and supply chain logistics of packaging 1 lb. sample bags of resin for marketing and sales

●Investigated and contributed to understanding the ASTM 2240 Shore A hardness assessment of resin for customer quality,

Worked with ARDL to test to understand if variability in hardness was due to the test and prep or the resin.

●Developmed and validated of spargingapperatus and process to remove water from a polydimethyl siloxane end terminated with -OH

Trelleborg Coated Systems– Process Engineer, Rutherfordton, NC facility

Jan 2019 – Dec 2019

●Designed and suggested new business process to guarantee materials are received in tolerance before PO is accepted or product is scheduled by planning

●IE calculations directed to capacity and when time locks would be violated. Excel SS developed for planning.

●Participated in a focus group for urethane coated fabric to identify issues leading to air retention failures. Optically inspected double filter and in process material for push thru. Helped understand the use of fluorescence in Raman by UTAS to make conclusions about curing of urethane coated fabric

●Failure analysis of customer field returns with associated corrective actions.

●Worked with the sales team to identify methods to detect low cure and fatigue defects to satisfy customer inquiry from Gasket Engineering Company.

●Specifically identified escapes due to curing in butyl rubber coated fabric and recommended corrective actions

●Optically characterized contamination defects in scrap over 9 yards as part of the appearance task force.

●Used DSC to characterize under-cure of butyl rubber coated fabric for gas ask application

●Have recommended and provided financial justification for FTIR to mitigate incoming material mistakes and identify solvent removal and detect extent of cure in chloroprene

●Reporting assembly and material defects and applying problem solving techniques to establish root cause root cause at the Calender. Saved over 50K USD in material scrap by implementing process improvements derived from DOE

●Implemented IR temperature sensor to monitor bank temperature of rubber and nip temperature of rubber to mitigate scorching and better understand how bank size affects ease of processing.

●Established new more consistent criteria to disposition expired rubber compounds via rheological testing. Reduced frequency of testing and cost of rubber waste.Worked with the Sourcing director to reduce the incidence of dispersion in calendar compounds leading to yield loss. Offered actions to Hexpol site to better detect poorly dispersed ingredients.

•Substituted new rubber ingredients in compounded rubber formulations due to obsolete ingredients. 10 formulas modified.

•Worked with quality engineering to optically characterize defects for ITT customer

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John Deere Commercial Tractor Division– Quality Engineer, third shift, one-year contract with Viva USA

Grovetown, GADec 2017 – June 2017

•Reporting assembly and material defects and applied problem solving techniques to establish root cause

•Determine if defects are of supplier origin or from manufacturing assembly

•Feedback defects found at end of line inspection to reduce defects of assembly origin via pareto charts and other Minitab Quality Statistics

•Suggest ways to error proof process to reduce defects of rubber hoses to prevent ill-fitting hoses caused by shrinkage from overheating and long heat history.

Mindsight and Guide point – Consultant to Rubber industry

Nov 2017- ongoing as requested

●Informed South Korea and Japanese clients on the technical aspects of rubber mixing for tire tread applications and specific structure property aspects of functionalized solution SBR used in automobile treads to reduce Payne effect of Silica filler

Milsco Manufacturing, a division of Jason – Manufacturing Engineer, Production Supervisor via People Link

Thompson, GAJanuary 2016 – March 2017

•20% improvement in productivity applying Lean Manufacturing –eliminating steps and error proofing processes Diagramed process flows and assessed cycle times with timing studies associated with processes improvements

•Iso 9001 auditing of calibration and work instructions-improved clarity of work instructions with labeled pictures

•Found the root cause to the John Deere mold issue and developed methods and cleaning procedures to mitigate the problem. Cleaning process was rolled out to JD sales locations worldwide

•Performed Gemba walks 3 days per week then followed up on corrective actions directed to 6S and process/work flow.

•Performed DOE directed to reducing voids in larger form factor projects, demonstrated iso/polyol pressure fluctuations responsible Improved in process yield by 75%

•Evaluated instrument suppliers for support and justified capex purchase of Karl Fisher Titrater instrument to test polyol for polyurethane foam. Set up lab procedures and tests.

•Assessed raw material quality with new Karl Fisher Titrator. Improved yield at least 10% over 1 year

•Developed and demonstrated quantitative method to determine isocyanate concentration as dispensed using FTIR

Bridgestone Firestone Corporation – Internal Technical Service

Senior Process Engineer for Formulation, Quality Assurance and Mixing

Graniteville, SC June 2012 – November 2015

•Formulation of rubber compounds for over 10 different tire components

•Compounding and high volume Mixing of Rubber

•Performed aging studies via Rheological measurements

•Created formulas to optimize cost by replacing carbon black in 3 compounds/qualified 3 carbon black and 1 sulfur supplier

•Wrote reports documenting power curves and mixing parameters for over 20 trials

•Systematically determined reclaim chlorobutyl was causing elongation to break and modulus out of tolerance conditions

oManaged material supplier to tighten specs for TC90.

oReturned to cost savings associated with the reclaimed rubber.

•Reduced reclaim material due to lumps by over 80%. Qualified and optimized mixing process parameters for Halobutyl rubber formulations for inner liner applications to reduce cured lump defects in finished goods. Used C13 solid state NMR to determine the exact polymer character of the lumps

•Created formulas and mixing process parameters to optimize downstream processing performance for thin sidewall low rolling resistance applications. Reduced die cut defects in extruded sidewall by over 60% by formulating with increased natural rubber

•Applied rheological test for Scorch, Mooney Viscosity, Tensile Tests, TC50 and TC 90 tests for lot acceptance-Specified FTIR, TGA-MS, solid state C13 NMR and SEM elemental analysis to solve recipe/formulation issues

•Qualified mixer tooling and 2 materials directed to cost savings of $150K to date

•Seasonally optimized tire carcass compound formulation for summer and winter factory conditions

•Responsible for daily Rubber Formulation and Rheology analysis using Alpha instruments

•Ensure Mixing Process Optimization to improve coverage of rubber to body ply fabric by optimizing Mooney viscosity and green strength. Increased natural rubber to improve green tensile strength

•Review and manage all materials testing and specification. Devised blending procedure to use off batches caused by low specific gravity; applied rule of mixtures to find final in tolerance specific gravity

•Material Qualification-Transfer to Manufacturing form Akron Research-worked with various chemical and carbon black supply vendors to qualify their materials for cost reduction and second source

Henninges Automotive – Quality Contract

Rockford, TN August 2011 – December 2011

Mechanical testing and Environmental testing of co-extruded/molded EPDM Rubber seals

•Compression, hardness, tensile, environment, chemical resistance testing of EPDM automotive seals subjected to reliability stress conditions

•Data collection, sampling, and associated statistical analysis

•Interpretation of GD&T drawings, ISO, ASTM, Ford, GM, BMW, Nissan specifications and test procedures

•Test improvement and development to reduce time, cost and to make more realistic of the field

Roane State Community College – Adjunct Instructor

Oak Ridge, TN February 2011 – December 2011

•Adjunct Instructor, AMTEC, Polymer Chemistry & Carbon Fiber Technology

•Developed Microsoft Power Point instructional material for delivery of basic polymer chemistry

Dutchess Community College and SUNY at New Paltz – Adjunct Chemistry Instructor

Taught Chemistry for majors and second semester Chemistry for Allied Health Majors-DCC, Poughkeepsie, NY August 2008 – September 2010

Co-Taught 1 semester graduate course in Polymer Chemistry 2005-SUNY New Paltz, New Paltz, NYfor majors and

IBM Corporation – Product, Applications, Process Development, and Patent Engineer

March 1988 – August 2008

Watson Research Center, Yorktown Heights, NY (2006-2008)

•Wrote patent application that provided solid 3D design review of design porotype prior to new product introduction

•Reviewed over 20 patent disclosures per month (over 200) to determine further action

•Drafted 10 research patent applications

•Conducted brainstorming session to flush out patentable ideas directed to PMMA/PS Nano-lithography process. Resulted in 15 US patent filings.

•Chaired JDA as IBM representative for phase change memory. Proved IBM invented Nano etch process prior to JDA

Microelectronics, Hopewell Junction, NY (1988-2006)

•Participated in first ISO 9001 certification and formal audit of the product engineering department in Microelectronics

•Suggested and implemented new business process to review ACICs designs for error prior to new product introduction

•Established original IBM Quality requirements for first IBM Microelectronics packaging modules-Bromont,Canada

•Specification development for OEM customers and improved new products introduction-GD&T and critical process specifications

•Improved and implemented new RFQ and RFI process to reduce response time to customer response

•Business process engineering to reduce steps, reduce design mistakes and error proof to reduce customer impact

•Black belt level training in Six Sigma and lean mfg. at IBM via University professors and internal DOE expert

•Received site quality award for qualifying polyimide polymer solution re-use for flip chip 121 chip MCM ceramic chip carrier vacuum impregnation process. Implemented Zahn cup to assure material. Saved over $7 M in material cost

•Awarded 6 US and 1 Japanese patents

•Evaluated polyaryletherbenzimidizole for Cu via passivation with a team from IBM Research. Co-authored paper in Journal of Adhesion Science.

•Developed polyimide to polyimide adhesion process to mitigate interlayer delamination when chem polishing step applied to polish polyimide and vias. Under curing of the first layer was used to drive interdiffusion of polymer chains at the interface to provide interfacial mechanical performance equal to the bulk polyimide.

• Developed product specifications for second source flip chip single chip ceramic ball grid

•Identified solvent induced cracking of polyimide dielectric coating, suggested and qualified alternative polyimide material

•Identified conditions leading to solder squirting through coating, improved coating cure to 100% yield by optimizing imidization

•Determined root of mouse bites in CMOS lines etched with HCl performing a Sputter Auger Study

•Optimized silane adhesion promotor apply to improve peel strength over previous process -IBM

•Performed kinetic study of plasma treated surface to determine maximum time between plasma cleaning and adhesion promotor application-wetting optimization using wetting angle and ESCA-IBM

•Developed diffusion empirical model to predict size of gas that would not diffuse readily through polyimide coating,but would easily detect a pore in the polyimide dielectric /metal thin film lines

•Qualified first 100 nF flip chip capacitor for mainframe computer applications. Paper presented in 1996 at the National ECTC Conference.

SKILLS

Microsoft Word, Excel, PowerPoint, Project, Minitab, Laboratory management software, Delphion, Lotus Notes, Deconvolution software, GD&T, Design of Experiments, SPC and DOE on Minitab 17, 6 Sigma Principles and statistics, Polarizing optical microscopy to assess liquid crystalline phase behavior, Optical Microscope Image Enhancement Software, MTS and Instron instrumentation and associated software, Thermo Fisher FTIR, DSC, TA,DMA 850,TGA, various Alpha Technologies Rheometers, Mettler Toledo Karl Fisher titration.

EDUCATION

Pennsylvania State University, University Park, Pennsylvania

Masters of Science, Major in Material Science-Polymer

●Thesis option to examine hydrogen bonding and its effects to improve compatibility of liquid crystalline forming polypeptides with alpha helix supporting solvents

●Studied model molecular composite of polyvinyl phenol and poly ethyl L glutamate via FTIR and polarizing optical microscopy.

●Proposed modification of Fluory-Huggins theory of mixing of rods with polymeric solvent to account for enthalpy of mixing due to side chain ester hydrogen bonding. Presented poster at Fall National American Chemical Society Conference in Toronto. 1990.

University of Massachusetts, Amherst, Massachusetts

Bachelor of Science, Major in Biology, Minor in Chemistry, Cum Laude

Post graduate chemistry major equivalent

CONTINUING EDUCATION

ASU -2 Short Courses on Coursera directed to basic design of statistics for Design of Experiments and Factorial and Fractional Statistical Designs of Experiments

Georgia Tech via Coursera, Department of Material Science, two short courses directed to physical metallurgy and metallurgy processing phase behavior Aug 2023

Online course in basic Solidworks-Introduction level

UMASS Lowell, Department of Polymer Engineering, Scientific Injection Molding Short Course, Aug 2022

CFPA, NJ, Validation of Analytical Methods in Pharma (21CFR 211,165(e) -2/2021

University of Tokyo, EDX short course Analytical Chemistry-1/2021

MIT-Cambridge, MA

●Summer short course –Viscoelastic Polymers and Composites

Purdue University

●ISO 9001 Internal Audit training for calibration and work instructions 2016

Univ. of Amsterdam

●Lean Six Sigma Data analysis with Minitab certification (t test, Chi Square, regression, ANOVA), Coursera 2016 and 2020

University of California at Irvine

●Project Management Fundamentals-Online Indeed short course, training at IBM

Piedmont Community College

●6 Sigma Green belt prep –Online Edtogo, Black Belt 6 Sigma on LinkedIn short courses 2020,originally trained at IBM

ORAU, Oak Ridge, TN

●ASM Short course- Metallurgy for Non-Metallurgists



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