Mechanical Engineer Product Development
Resume:
Andy Bordon
**** ****** ******** *****, *-***. Englewood, CO 80112
*********@*****.***
Professional Summary
Senior mechanical engineer with 5 years expertise in new product development within the medical device industry. Strong background in R&D of devices, with a specialty in design through prototyping, testing, analysis and documentation. Extremely motivated by novel products and concepts, with proven success in independently and/or collaboratively completing assignments requiring innovative solutions. Seeking upward mobility, exposure to new technology, a well-rounded culture, and a challenging learning environment. Skills
Model and drawing packages in Solidworks [5 years]. Design control with EPDM [3 years].
Product development GD&T, tolerance stack-up,
prototyping, inspection, DFM and systems integration.
Manufacturing process development (injection molding, hot plate and ultra-sonic welding, thermoforming).
Practical application of theory (materials, statics, thermal, fluids, circuits- LEDs and detectors).
DHF and DMR management –Risk analysis, DFMEA, PFMEA, Traceability matrix.
Problem solving, root cause analysis, and DOE. Design transfer and supplier relations.
Experimental design, lab testing and data analysis. New product development, from concept to clinical trials. Experience
Mechanical Engineer Baxter Healthcare Operations January 2016 – Present
Scheduling and supporting the planning and management of multiple injection mold overhaul, development, and qualification projects.
Leading technical reviews covering critical features, assembly automation, risk analysis, and molding capability of class II medical devices.
Managing ECO and CCM packages (models, drawings, specifications, BOMs) related to new mold development.
Supporting new product development by coordinating with cross functional teams, providing modeling expertise, and offering technical insight for molded components.
Solving manufacturing problems related to molding, inspection, and automation issues. Product Engineer Ameda Engineering May 2015 – January 2016
Co-managed research, development and sustainment of class II medical devices, for both on –market and new products.
Lead new product development, driving product design, prototyping, documentation, design verification, manufacturing development, and validation.
Managed DMR and DHF change packages (drawings, models, specifications, BOMs, risk files, and procedures).
Coordinated with cross functional teams to maintain project schedules. Mechanical Engineer Fresenius Kabi (Fenwal) Disposables April 2013 – May 2015
Responsible for research and development of class II medical device, from conception to market release.
Resolved the technical challenges related to conception, materials, design, prototyping, systems integration, verification, validation, manufacturing, inspection, sterilization and packaging.
Managed model and drawing packages, complex system assembly tolerance stack-up analysis, and lead cross functional team design reviews.
Independently defined component, subassembly and process acceptance criteria, specifications and verification test procedures.
Managed procurement of materials, components, and subassemblies from suppliers –foreign and domestic. Test Engineer Hospira Consumables March 2012 – April 2013
Collaborated with development engineers to design and execute studies of several prototype and production class II medical devices.
Designed and implemented test procedures, meeting ISO and other regulatory test standards.
Documented test results following design traceability protocol and GDP.
Used hands-on approach to and adapt lab equipment to satisfy test equipment requirements (Instron, pressure and torque gauges, etc.).
Education
B.S. Engineering Physics
B.S. Applied Mathematics
University of Colorado at Boulder
3.56 GPA
2006 – 2011
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