SUMMARY Professional, dedicated and resourceful engineer seasoned with extensive experience in Manufacturing Operations, R&D, Process & Product Development and Validation of medical devices and plastics and rubber products and processes and Quality.
EXPERIENCE
Fulflex Inc. (a division of the Moore Co.) Brattleboro VT. 2010 - Present
Technical Manager
• Management of the product development, process development and manufacture of TPE and TPU extruded film and sheet products.
• Responsible for Plant Quality and Lab for Rubber products manufacturing and development.
• Facilitated transfer of products and processes from overseas plant.
• Implemented quality systems and modernized data collection.
• Analyzed trends and production challenges, and implementation of corrective actions.
• Handled customer concerns
Teleflex Medical, Jaffrey NH 2007- 2010
Sr. Extrusion Engineer
• Ownership of process from inception to sustained manufacturing.
• Specified and implemented1.5M in capital equipment and tooling.
• Initiated and executed cost improvement programs totaling est. $350K/year using Lean Six Sigma; Five S, Value stream mapping, SMED, Kaizen, Poke-Yoke, KanBan, JIT, DMAIC.
• Project management of cross-functional teams, creating and driving project plans.
• Responsible for outsourcing compounding of polymers and sustaining internal compounding operation.
• SME for designing and developing customer components and problem solving.
• Responsible for teams to write and execute IQ/OQ, and PQs for equipment and processes.
• Developed equipment and process for the manufacture of FEP heat shrink.
• Created and implemented training program for extruder operators and technicians.
• Initiated Intern program
Boston Scientific, Watertown Ma. 1982 – 2006
Sr. Manufacturing Engineer/Supervisor - Plastics Manufacturing 2003 – 2006
• Managed Plastics Manufacturing Operations and Engineering with 25 direct reports. (Extrusion, Molding, Ultrasonic welding, secondary operations and assembly)
• Led cross-functional project teams for releasing components for new products.
• Responsible for customer satisfaction; supplying and meeting needs of sister plants, meeting needs of R&D for new product release.
• SME on revalidation team that included review & rewrite of all associated documentation from Design Specifications, FMEAs to Equipment IQ/OQs, Process DOE, Process OQ and PQs. (Horizon)
• Developed, wrote and updated processes, procedures, and specifications.
• SME for External Audits. Responsible for training of personnel.
• Transferred manufacturing technologies and processes to multiple sister plants.
• Led Core teams to solve issues and implement solutions with products in the field.
• Created and maintained project timelines.
• Troubleshoot/Continuously Improve manufacturing processes, and lead efforts to increase yields and lower costs using Six Sigma tools.
Sr. Development Engineer R&D 1999 – 2003
• Managed Engineers and Engineering Technicians.
• Worked on multiple Core Teams to convert marketing requirements to design requirements and develop catheter and processes to meet design requirements for medical products.
• Core Team Member to solve issues in the field and to implement corrective actions.
• Core team leader for new product development and commercialization.
• Specified, procured and validated complete custom manufacturing lines.
• Temporary transfer to Ireland Plant to facilitate product transfers.
• Prepared, and presented plastics technologies at annual divisional and quarterly Polymer Science Process Council meetings.
R&D Process Engineer 1995 - 1999
• Responsible for developing, and commercializing microcatheter products with proprietary Variable Stiffness and braiding technologies.
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