Medical Textiles and Catheters Specialist: New Products, Tubing, Fibers, Films, Sutures and Antimicrobial Industries.
Technical Consultant #2033
- 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).
- Fiber technology (wet and melt extrusion).
- Medical Textiles (nonwovens, biodegradable, antimicrobial).
- Fluoropolymers (extrusion).
- Catheters (guidewires, aspiration).
- Tubing, films, laminates.
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).
- 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
- Current in computer skills and advanced communications.
- Lean Six Sigma trained.
- 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
- Ph.D. Chemical Engineering, (Fiber Technology), Textile Institute, Leningrad, Russia
- M.S. Chemical Technology, Textile Institute, Chemical Engineering Department, Leningrad, Russia