Medical Textiles and Catheters Specialist: New Products, Tubing, Fibers, Films, Sutures and Antimicrobial Industries.

Expertise

• Medical industry product and polymer expert, (polyolefins, nylons, polyesters, elastomers, PLLA, PGA, fluoropolymers) utilizing compounding, extrusion, lamination to produce tubing, fibers, films for wide variety of products - catheters, sutures, and antimicrobial nonwoven laminates.
• Surface modification specific to hydrophilic, hydrophobic treatments; friction adjustment; protective, flame-retardant, antistatic, adhesives, and coatings.
• Skilled in project management, quality control, laboratory tests and ISO regulations.
• Product and Materials Development Engineer proven result-oriented professional with strong problem-solving skills, analytical abilities and extensive hands-on experience in polymer engineering and special expertise in medical devices (catheters, drapes, and sutures).
• Start-up of the lines,tubing and spun bond extrusion, coating, and adhesive film lamination.
• Commercialization of novel products; complete product development cycle from internal development to managing external customer interactions.
• Tools and technology utilize: FTIR spectroscopy, gas chromatography, optical microscopy, thermal and dynamic mechanical analyzers (DSC, DAM, TGA -TA Instruments), mechanical tensile testers (Instron, Zwick) and Rheometer (Dynisco, TA Instruments).

Specialty Products

• Fiber technology (wet and melt extrusion).
• Medical Textiles (nonwovens, biodegradable, antimicrobial).
• Fluoropolymers (extrusion).
• Catheters (guidewires, aspiration).
• Tubing, films, laminates.

Experience

Independent Consultant, Present

• As a Senior Manufacturing Engineer working on an extended product development team or existing products, developing manufacturing methods, systems and processes to produce a high quality product at optimal cost.

Terumo Medical Corporation, Elkton, MD, Sr. Product Development Engineer, 2007 - 2013

• Lead the extrusion element, adhesives, and coatings - materials and equipment selection for new catheter product development from concept to production.
• Twin screw compounding of thermoplastic elastomers with inorganic radiopaque filler.
• Responsible for all portions of capital extrusion and coating engineering projects ($1 million) - system design, equipment design, capital requests, project status, supplier/customer interface, operations training, and start-up.
• Developed and extruded dilator tubing for 5F and 8F Destination® Guiding Sheath.
• Created and executed protocols and reports for engineering studies; Installation, Operational, and Product Qualifications (IQ/OQ/PQ) on process equipment and tooling; design verification, design validation, raw material specifications.

Fluoropolymer Resources, Willimantic, CT, 2006 - 2007

Senior Product and Process Development Engineer

• Introduction of new technologies for recycling of fluoropolymers from cable waste.
• Single screw compounding of Teflon®.
• Worked on the analytical method with Institute of Material Science (University of Connecticut) for the plastics blend evaluation after electrostatic separation.

Teleflex Medical, Technical Center, Mansfield, MA, 2005 - 2006

Senior Product Development Engineer

• Suture product development (PLLA, PGA, PET, UHMWPE - Dyneema® Purity) for cardiovascular and orthopaedic applications including design requirements, design controls, design verification, GMPs, and regulatory requirements) and product design and manufacturing methods (including molding, extrusion, sterilization, and biocompatibility).
• Research of suture coating method for encapsulation of water soluble drugs.

Ahlstrom Windsor Locks LLC, Fiber Composites Div., Windsor Locks, CT, 2002 - 2005

Senior Product Development Scientist, Medical Group

• Responsibilities included developing, commercializing and optimizing new nonwoven medical products for the major customer of the company.
• Protective apparel team member: Coordinated manufacturing trials with operations personnel and production crews of five to seven operators.
• Supervised scientists, engineers, technologists and technicians.
• Worked closely with sales and marketing for new business developments; interacted with multiple customers and vendors.
• Product development of advanced nonwoven medical products and composites (proposed eight new laminate structures - five commercialized).
• Played key role in start-up of the new spun bond and adhesive lamination facility, (output of production lines increase by 50-80% in the first manufacturing year).
• Responsible for maintaining and updating patent database related to nonwovens and medical textiles.

Foss Manufacturing Company, Inc., Hampton, NH, 1999 - 2002

Research Engineer, Plastics and Fibers; Research and Development Department

• Provide leadership in developing new concepts from initial design to commercial release, conducted feasibility studies to determine process capability and functional performance of new nonwoven for wide variety of products - medical, filtration, and footwear.
• Provide technical support to manufacturing for new process start-ups, enhancements and improvements. Developed new test methods to better predict and understand product performance in use.
• Product manager for development of advanced antimicrobial fibers with additives AEGIS, AgIon, Alphasan.
• Design and implementation of high performance technological processes of fiber spinning, composites, laminates, and extrusion and coextrusion coating.
• Coordinated pressure test method to correlated results from different pigment suppliers.

Albany International Research Co., Mansfield, MA, 1997 - 1999

• Senior Research Engineer, for the polymer processing group.
• Investigated new polymers and their potential to be processed in advanced fiber and film products for filtration, paper clothing and medical products.
• Responsibilities included equipment selection and processing parameters optimizations. Interacted with Sales and marketing for efficient customer orders processing; supervised two technicians.
• Member of the Cost Team, Library Committee, and Safety Advisory Committee; and supervised technicians.
• Managed technical projects and product development of new fibers and monofilaments.
• Interacted with clients (Boston Scientific Corp., Ortec Int., Sherwood-Davis & Geck, Metabolix, Smith and Nephew GRC, Colgate, Monsanto and others) to plan and execute trials.
• Conducted research and production of novel biodegradable monofilaments and fibers for stents and scaffolds from collagen, alginate, Biopol (PHB), PLLA, PGA, and polycaprolactone.

Haremar Plastic Manufacturing Ltd., Toronto, 1996 - 1997

• Chemical Engineer and Analyst for the blown film plant.
• Created and managed testing facility.
• Increased testing throughput 50% by standardizing testing lab.
• Created SOPs, established sample and testing trace-ability; instituted rigorous calibration and promoted cross training of instrument operators.
• Worked closely with manufacturing management to optimized existing products.
• Created and maintained database of quality reports.

Amraz Packaging Ltd., Israel, 1992 - 1995

• Quality Control Supervisor for the Injection-blow and molding plant.
• Responsibilities included overseeing quality control laboratory activities, analyses of bottles and food packaging and developing specifications and incoming inspection test methods.
• Analyzed quality and structure of polymers with help of viscosimetry, gas-chromatography, and thermo mechanical tests.
• Laboratory management, equipment maintenance, calibrations and repair: Perform calibrations and repairs on analytical chemistry instruments.

Synthetic Fibers Research & Development Center, Russia, 1983 - 1991

• Senior Research Engineer working with the polyamide fibers department.

Research and Development

• Oversaw projects for development polyamide fibers for existed and new chemical fibers producer.
• Product development from bench top to pilot and industrial scale for wide range of polyamide industrial and special fibers (5 and 29 tex).

Manufacture

• Manufacturing experience in spinning textile and industrial polyamide fibers.
• Participated in design, modification and tests of factory equipment.
• Prepared contract documents, reports and recommendations.
• Developed programs of sampling and analysis of fibers to maintain quality.
• Standards of manufacturing production and for new materials.

Honors & Publications

Credentials

• Current in computer skills and advanced communications.
• Lean Six Sigma trained.

Masters Thesis

• Wet Spinning of Alginate Fibers for Medical Materials
• Modification of alginate fiber by antibiotics kanamycin and adjustment of drug release
• Degrees evaluated by Foundation for International,(Textile Institute, Chemical Engineering Department, Leningrad, Russia)

Academic and Professional Affiliations

• Department Of Education Workshop, Albany International Monofilament Plant, Homer, NY
• Leistritz Twin Screw Workshop, Somerville, NJ
• IR Spectroscopy Course, Bowdoin College, Brunswick, ME
• Medical Textiles Conference, Clemson University, SC
• American Society of Testing and Materials Committee F23 on Protective Clothing, Tampa, FL (ASTM)
• American Kunhe Technical Medical Extrusion Seminar, Las Vegas, NV
• Medical device conferences: MD&M, TCT, ISET
• Society of Petroleum Engineers, Philadelphia Section, Board of Directors (SPE)
• Reviewer for Plastics Design Library at Elsevier (PDL)

Publications and Patents

• Author of educational and study text
• 2 U.S. Patents

Education

• Ph.D. Chemical Engineering, (Fiber Technology), Textile Institute, Leningrad, Russia
• M.S. Chemical Technology, Textile Institute, Chemical Engineering Department, Leningrad, Russia