Timothy Meluch, PhD (Retired)

Experience

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  Hercules Incorporated

  Jan 1988 - Jan 1991

  Research Engineer

  Developed additives for RIM poly(dicyclopentadiene)• Developed compounds that increased high temperature stability 100%; reduced coating discoloration 75%• Formulated a new stabilizer package which preserved impact and tensile properties and reduced product cost 5% ($160,000 annual savings)Developed a release backing based on polypropylene film• Developed proprietary additives reducing the release force of standard adhesives by 30% to 50%Reduced H2O transmission through polypropylene packaging film• Developed a proprietary additive which reduced H2O transmission by 15%Responsible for research-scale testing laboratory• Supervised two senior technicians• Coordinated scheduling for sample production and physical property testing for a group of ten investigators Show less

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  ActiMed Laboratories, Inc

  Jan 1991 - Jan 1994

  Project Leader

  Coating formulation and processes to produce indicator strips for medical diagnostic devices• Developed coating formulation, as well as scale-up, specification, testing, and daily operation of coating processes• Improved blood compatibility of thermoformed PET device housing using blood compatible surface treatments• Production process patented:McGeehan, John K.; Ertingshausen, Gerhard; Meluch, Timothy B., “Manufacturing Process for a Sample Initiated Test Device,” U. S. Patent 5,411,858, May 2, 1995. Show less

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  Althin Medical, Inc.

  Jan 1994 - Jan 1999

  Research Manager

  Supervised a group of two exempt and four non exempt personnelLed development of new hollow fiber dialysis membranes from synthetic materials• Developed product and process from laboratory (1 Kg) scale to semi pilot (100 Kg/d) spinning line• Produced product for initial human clinical trials• Fiber spinning process patentedMeluch, Timothy B.; Chiang, C.-Y.; Jaanine, H., et. al., “Melt Spun Polysulfone Semipermeable Membranes and Methods for Making the Same,” U. S. Patent 6,218,441, Apr. 17, 2001 (Process claims)• Membrane composition of matter patentedMeluch, Timothy B.; Chiang, C.-Y.; Jaanine, H., et. al., “Melt Spun Polysulfone Semipermeable Membranes and Methods for Making the Same,” U. S. Patent 6,881,377, Apr. 19, 2005 (Composition-of-Matter claims) Show less

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  Baxter Healthcare

  Jan 1999 - Jan 2010

  Led team focused on delivering new products, while developing and executing product roadmap. Provided day to day team leadership while meeting long term Corporate needs.• Formed and led Chemical Engineering group of 6 professionals with $750K annual budget, managing staff on multifunctional / multidivisional project and problem-solving teams and delivering promised results within time and budget constraintso Integrated new high-performing group into a functional team by recruiting successfully through well-developed position descriptions for organizational levels• Served as functional owner of technology development project for Global Infusion Systems / Specialty Therapies and led multifunctional (mechanical, material, and chemical engineering) team, designing and developing new flow regulating devices for infusion markets and overseeing experimental design and statistical analysis of datao Delivered functional prototype and predictive mathematical model of device performance Show less • Led technology development, external, and University collaboration effortso Executed effective design methods at department level, coaching and mentoring for effective DFSS implementation on technology development projects o Reduced late-stage design failures by providing critical review of development efforts as retained independent examiner for multiple internal disposable product development teamso Supported qualification of Renal Division dialysis fiber supplier (technical due diligence), confirming production capability and quality levels supporting contracto Championed university collaboration effort on microlayer extrusion technology for packaging applications (Case-Western Reserve), demonstrating technical feasibilityo Facilitated product improvement efforts based on sequential Design of Experiments (DOE) by developing design, test methods, and specifications for disposable / external hardware interface Show less Directed and collaborated with technical personnel while gathering, analyzing and interpreting scientific data. Communicated results via written reports and presentations internally and to clientsContributed to defect resolution and innovative technology development.• Eliminated defects that saved $100K per year in added cost by conducting a DMAIC investigation and identifying root cause at subcomponent manufacturer for a 5x defect spike in existing Pharmaceutical product line; developed and qualified material release test to prevent recurrence• Reduced active viral load and allowed product development work to proceed by designing, developing, and installing laboratory-scale UVA viral inactivation apparatus in support of human plasma purification initiative• Assigned to provide rapid response to imminent arrival of high value transgenic piglets that could not be exposed to ambient environment so as to avoid viral or bacterial contamination by creating and fabricating custom isolation chambers that functioned as designed for cesarean delivery o Received Corporate Technical Award for efforts• Delivered technical solutions for $3M budget program• Coordinated company / university NIST/ATP joint development project for virus removal hollow fiber membranes by designing, developing, constructing, and operating laboratory scale melt spinning equipment, selecting polymer materials and diluents for membrane development, and demonstrating production of nanoporous hollow fiber membranes by thermal phase inversion o Completed project on time and within budget, demonstrating design feasibility Show less

  • Director, Engineering

    Jan 2009 - Jan 2010

  • Technical Director, Engineering

    Jan 2007 - Jan 2009

  • Sr. Research Scientist

    Jan 1999 - Jan 2007
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  Baxter International Inc.

  Jan 2011 - Jan 2018

  Technical Director

  Developed and implemented product innovation strategies as defined by core business groups, including new products and materials to fulfill identified market and customer needs. Provided technical leadership, fostered open communication, and drove decision making to enable new investment, greater profitability, and technical excellence• Tasked to reduce leak defect rate on large-volume renal product as regulatory scrutiny and customer complaint rates were rising and Operations demanded a major design change unsupportable under existing cost structure, achieving 90% reduction o Led team to conduct global product defect review across 7 countries using DMAIC methodologies, demonstrating root cause of local process changeso Defined and validated critical performance stress test, allowing process optimization• Assigned primary technical lead role for new renal product line targeted to China, as R&D office was partially equipped and staffed, while development timelines were aggressiveo Coordinated with China Corporate resources to complete technical staffing required and oversaw laboratory fit out, providing sound basis for program executiono Provided full technical oversight, data review, decision support, and daily communications, ensuring all project and Corporate milestones were achieved over 18-month timeframe and demonstrating design feasibilityo Oversaw due diligence and specification development efforts for China suppliers, allowing Purchasing and Supply Management to initiate supply contract negotiations for key components Show less

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  3305 Consulting, LLC

  Apr 2019 - Dec 2022

  Principal

  Experienced, capable leader and innovative engineer with extensive international medical device research, product development, and support experience. Excellent analytical and problem-solving skills in product design, material research, process development, and statistical analysis. Talented innovator, effective organizer, and critical thinker with outstanding research and project management skills. Available to discuss consulting opportunities, please contact me directly at TBM.3305.consulting@gmail.com Show less