• Proven self-starter whose expertise spans Test Engineer and Electrical Engineer with Printed Circuit board design experience. Strong logical decision making process for interpreting requirements to write test plans, protocol, execution and overseeing the running of tests for new design and life cycle engineering. Proven track record of quickly learning new technology and tools. • Innovative problem solver, who has demonstrated sound judgment and attention to detail. Adept at handling multiple projects. An ability to prioritize and multitask on numerous design and engineering efforts. • Relevant Software ,DOORS, MKS, Clearquest, Labview, Environmental Chamber for CSA testing, IEC60601-1 2nd and 3rd Edition, MathCAD, SAP, MatrixOne, Mentor PowerPCB, Cadence Orcad, CAM350, AutoCAD

Senior Project Engineer-medical device/Quality supervisor @ Senior Project Engineer responsible for developing test data plan, execute the test for Medical Device industries and measuring equipments industries. Responsible to write test report for all IEC 60601 2nd and 3rd edition for medical devices and IEC 61010-1 2nd and 3rd edition for measuring equipment standards in order to certify the individual products. Work closely with companies to ensure the certifications. Knowledge on risk management file for IEC 60601-1 3rd edition as well as ISO 14971 and IEC 61010-1 3rd edition for risk management file. Mentoring young engineers and review their reports. From April 2015 to Present (9 months) Project Engineer-medical devices @ Project Engineer responsible for developing test data plan, execute the test for Medical Device industries and measuring equipments industries. Responsible to write test report for all IEC 60601 2nd and 3rd edition for medical devices and IEC 61010-1 2nd and 3rd edition for measuring equipment standards in order to certify the individual products. Work closely with companies to ensure the certifications. Knowledge on risk management file for IEC 60601-1 3rd edition as well as ISO 14971 and IEC 61010-1 3rd edition for risk management file. From August 2012 to Present (3 years 5 months) V & V Engineer @ • Responsible for developing and executing internal V & V Plans, Protocols and Test reports for highly regulated FDA environment for New Product Development and Life Cycle Engineering (LCE) in both hardware and software projects. Coordinated manpower for internal test execution and coordination of testing for external Test Houses (4Square, ISTA, CSA, etc.). • Participated in V&V Continuous Improvement team to simplify templates and streamline Matrix 1 processes. • Lead Engineer for LCE (Spectris Solaris EP). Designed electrical tests in accordance with MEDRAD production equivalent processes, which required finding a replacement for obsolete part. Recorded data for test report in preparation for new board design. Efforts resulted in printed circuit board that was more cost-effective and efficient than old model. • Lead V & V Engineer responsible for developing test protocols on multiple projects for submission to CSA. Wrote MEDRAD test report per National Deviation, IEC60601-1 and IEC60601-1-1, 2nd and IEC60601-1 3rd edition report. • Worked closely with design team and internal Regulatory Affairs Department to ensure that all products met FDA and CSA standards. • Participated in internal factory audit, which identified obsolete parts in several products. Wrote report outlining which new critical components would be needed to meet CSA IEC60601 2nd edition standards. • Knowledge of MRI safety and potential hazards of magnetic field, particularly as it relates to MR injector. Also familiar with testing requirements of CT injector as it relates to CT scanner simulator. From September 2009 to August 2012 (3 years) Principal PCB Designer @ • Actively defined new design circuitry for Head Neck Spine Coil which required decomposing stated requirements and electrical power distribution by calculating diode strength to stay within defined power budget distribution. Designed schematic, selected the diode to be used, and designed the detailed PCB (2 layers) used in the final product for distribution. • Part replacement analysis of OP Amp for the SPO2 accessory to the patient care monitor. Analyzed and coordinated release of new OP AMP for transfer to in-house manufacturing division. Designed a complex 6 layer Flex Circuit board with embedded cap between all layers. • Designed interchangeable multi-layer boards that worked with both monitors and injectors, allowing engineers to reuse instead of designing a new board. Board was designed specifically for MR suite, assured that no artifacts on patient image based on the board use of electrical components. Designed a complex 6 layer Flex Circuit board with embedded cap between all layers. • Active member of designing requirements/checklist for selection of “approved” board houses for MEDRAD. Ensured that board houses met FDA and IPC standards. Conducted on-site audits of board house processes and made recommendations and decisions for MEDRAD. From January 2001 to September 2009 (8 years 9 months) PCB Designer @ PCB and Hybrid Circuit Board Designer Developed a schematic capture library for new layout procedures to export the netlist into Protel PCB design software for new startup company Laid out unique circuit board designs which involved in wire bonding techniques and printed resistors techniques on high volume Surface Mount Crystals. From August 2000 to January 2001 (6 months) Electrical Engineer @ Responsible for creating custom designs by communicating directly with the OEM to take order, design, overseeing the technician for assembling, test the prototype and send the prototype to the OEM for approval Managed the design process from initial sales rep inquiries through production, design, prototype, and testing Developed product and tooling cost estimates by communicating with manufacturing and created in Excel Provided quotes to sales reps, and advise of economic merit for each potential sale From December 1999 to August 2000 (9 months) Hybrid Circuit Board Designer/Electrical Designer @ Created the layout for high-volume circuit boards for DC-DC converters by using wire-bonding techniques and printed Resistors by using Protel software Responsible for creating schematic drawings from engineering sketches to electronic format in order to export to Netlist. Interacted with vendors to specify components and substrates for New Product Development. From June 1999 to December 1999 (7 months) Mechanical Designer @ Responsible for designing a series of 19" chassis for fiber optic communication products that successfully supported new sales in both custom and standard product segments Designed mechanical packages for PCB enclosures working closely with electrical engineers and technicians Assisted with vendor selection for metal fabrication by site-visit and price negotiation Created all assembly drawings and bills of material to support production of designs Solved company's in-house manufacturing problems Learned PADS software for laying out printed circuit boards Tools/Programs DOORS, Mentor Power PCB, Orcad, BluePrint, CAM350, View Logic, SAP, Matrix, AutoCAD 2008, Protel, MS Office and Project 2003, MatrixOne, MKS, Clearquest, LabView, Environmental Chamber for CSA, IEC60601-1-2nd Edition testing, MathCAD, Xilinx ISE From November 1990 to May 1999 (8 years 7 months)

EET, Communication/Electronics @ Point Park University From 2005 to 2009 BS, Electrical Engineering Technology; general electronics @ Point Park UniversityAssociate of Science, Electrical drafting and design technology; computer aided drafting and electrical drafting @ New River Community College From 1984 to 1986 Michelle Loeffler (Choo) is skilled in: Design Control, FDA, ISO 13485, Embedded Systems, Medical Devices, Electronics, Manufacturing, Engineering, Labview, Product Development, Electrical Engineering, PCB design, Testing, Product Design, Continuous Improvement