SummaryBiomedical engineer with 4 years of experience in a wide array of roles within a highly regulated medical device development environment. Experienced in design, development, and testing of medical devices in both self-managed and team-based settings. Comfortable multitasking and flexible to changing priorities. Extensive experience in performing engineering vendor audits with proven results in the form of high quality parts for medical devices. Aptitude for innovation and thinking outside the box demonstrated through various IP submissions. HighlightsHighly experienced in product development cycle, FMEA (design, software, and process), verification validation protocols (IQ, PQ, OQ) and systems testing, risk management and mitigation, vendor selection and audit.Proven capacity of creating new and efficient manufacturing techniques for medical device manufacturing per cGMP guidelines.Extensive experience auditing suppliers and collaboratively working towards improving supplier quality to meet requirements.Experienced in identifying key product specifications and drafting easy-to-understand and efficient quality specifications for manufacturing. Highly experienced in training production personnel on the same.Pioneered advances in sterilization for battery operated portable medical devices. Familiar with EO, gamma, e-beam, and steam sterilization techniques.Successfully completed Root Cause Investigation training for CAPA offered by Weaver Consulting, LLC.Successfully completed the UL Knowledge Services training course on Designing for Compliance to IEC 60601-1 3rd Edition.Computer skills and past experiences StatGraphics, Minitab, ProE, Solidworks, and Microsoft Application Packages. Experience07 2009toCurrentProduct Development Engineer Streetsboro,OH,UrologyPrimary responsibilities include managing and integrating regulatory, quality, marketing, and manufacturing efforts to successfully design and develop disposable medical devices.Cross-functional team leader for researching market scope, current technology, and resource requirements for establishing new product portfolios within Cook Medical s Urology business unit.Comfortably led project development activities in a virtual team environment interacting with R D and manufacturing teams around the globe.Effectively audited various suppliers to identify root causes of material non-conformance and addressed issues in a timely fashion.Individually drove a first of its kind catheter development project from research to sign-off. Performed extensive process capability studies and tooling validations via IQ, OQ, and PQ.Currently developing a high-pressure drug eluting balloon catheter.Pioneered a catheter to meet pressure-sensing requirements in urological applications.Performed extensive gap analyses to re-affirm quality of legacy products (such as urological dilation catheters, stents, and wireguides) for launch in Asian markets per JIS and GB standards.Currently implementing cost saving initiatives for certain access catheters estimated at reducing manufacturing cost by 60-80 percent by performing extensive supplier qualifications.Diplomatically resolved conflicting expectations between Cook and other companies avoiding potential law suitsApplied knowledge of ISO 14971 Risk Management System, ISO 13485, 21CFR 820.30, and MDD 93 42 EEC Quality Management Systems.Currently mentoring junior employees to enable well-rounded and holistic employee growth.01 2008to08 2008Electrical Engineer, Co-opAmetek, Inc. Austin,TX,Hands on experience in simulating and testing Timing Control Hubs, LVDS-LVPECL buffers, EEPROMs, Transistor based Switching Circuit modules for touch-screen displays of various Computer Operator Interface devices.Assisted in researching efficient IC substitutes for Rockwell Automation s Panel View Plus line of products.01 2008to12 2008Undergraduate Research AssistantMks Instruments Inc Union,SC,Responsibilities included developing various signal processing algorithms for XBAT- an open source sound analysis application in Matlab. EducationExpected in2009totoBachelor of Science Biomedical Engineering, BiologyMarquette University-Milwaukee,WIGPA Marquette University, Milwaukee, WI 2004-2009 Bachelor of Science, Biomedical Engineering. Minor Biology Engineering GPA 3.5 4.0 SkillsEngineer, Access, Balloon Catheter, Catheter, Catheters, Cost Reduction, Iso, Its, Manufacturing Cost, Marketing, Medical Devices, Mentoring, Product Development, Product Development Engineer, Project Development, Risk Management, Stents, Tooling, Trading, Transmissions, Welding, Biomedical, Algorithms, Matlab, Open Source, Signal Processing, Electrical Engineer, Mechanical electrical Engineer, Switching, Testing, Audit, Auditing, Audits, Capa, Cgmp, Corrective And Preventive Action, Drafting, Exchange, Fmea, Medical Device, Minitab, Mitigation, Multitasking, Patent, Product Specifications, Proe, Progress, Solidworks, Sterilization, Supplier Quality, Systems Testing, Training, Validation Protocols, Vendor Audits, Vendor Selection, Wireless  SEP  Software Engineer (12-month contract REMOTE, team based in Mounds View, MN) W2 Candidates ONLY Top 3 Skills 1. JavaScript2. Vue.js3. Gitlab Required Knowledge and Experience Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience. Other relevant software development Must Haves DockerJSONPostgreSQLreact.jsREST APISpring BootSpring FrameworkSQLVue.JSXML Preferred Software experience flaskGrailsGroovyPython Duties Participate in requirements formulation, design, prototype, develop, and documentation of the software applications and ensure the solutions meets all requirements.Help determine technical direction for multiple projects to streamline workflow efficiencies.Will be responsible for creating brand new solutions with support to meet business process needs.Strong communicator with senior internal and external customers and vendors.Designs, develops, tests, debugs, and implements operating systems components, software tools and utilities.Determines systems software design requirements.Ensures that system improvements are successfully implemented and monitored to increase efficiency.Generates systems software engineering policies, standards, and procedures.