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MICHAEL V. PHENNER

42 Locust Street, Merrimac, MA 01860

(978) 273-5664 / EMAIL: Michael@Phenner.com

SUMMARY

Results driven Quality Test Development & Validation Engineer with hands-on experience in medical device testing and personnel management in secure QA / R&D laboratory environments. Highly motivated individual with excellent organization, communication, and technical problem solving skills. Proven track record of consistently demonstrating the ability to handle multiple task demands with competence and integrity to high quality standards … while also meeting critical deadlines. My areas of expertise include:

► Develop & validate medical devices per ISO13485 & ISO17025 for R&D, QA, & Manufacturing.

► Perform medical device test fixture verification, validation, HALT testing in controlled laboratories

► Manage lab EMC/Safety testing per FCC,FDA QSR,OSHA,ISO13485,ISO17025,UL/EN/IEC 60601

► Author FMECA , IQ/OQ/PQ, SPC specifications, procedures, and test reports per FDA 21CFR 820

► Test, diagnose, and repair complex SMD/Through-hole circuitry & systems to the component level

► Oscilloscopes, Logic/Spectrum Analyzers, Emulators, DMMs, Mech./Chem./Mag./Temp. Sensors

- OS/Apps: Windows, Unix, LabVIEW, MiniTab, SolidWorks, MS Word/Excel/PPT/Access/Project

PROFESSIONAL EXPERIENCE

Quality Assurance Engineer @ ESA Biosciences : Chelmsford, MA [4/08 - Present]

○ Designs specialty high-performance liquid chromatography (HPLC) instruments and Reagents ○

● Assist in new product designs including risk analysis, design verification & validation testing for Mfg.

● Implement/manage internal and supplier based Corrective And Preventive Actions & tracking systems

● Maintain Quality System in accordance with ISO13485:2003, ISO9001:2001, FDA QSR (21CFR:820)

● Internal & external auditing to assess compliance with Quality System & identify improvement areas

● Manage calibrated equipment, preventive maintenance, personnel training, CAPA & tracking systems

QA Performance Test Engineer (& manager) @ OmniSonics : Wilmington,MA [12/05 - 11/07]

○ Develops catheter based ultrasonic technology solutions to treat Vascular Occlusive disease ○

● Created designs, test fixtures, procedures, reports for characterizing intravascular ultrasound devices.

● Authored component / system level testing procedures and ECOs for new & existing product designs

● Performed blood clot ablation device prototyping, endurance/NDT tests, verifications, & validations.

● Hired/managed highly skilled electrical/mechanical R&D Engineers, Technicians, & test laboratories.
● Reduced open issues by 75% as Manager of Corrective And Preventative Action (CAPA) committee,

QA Test Engineer (Contract) @ RSA Security (Div. of EMC) : Bedford, MA [10/04 - 07/05]

○ Premier provider of cryptography & data security devices & solutions for business acceleration ○

● Performed in-house hardware and software security token testing, verifications, and DFM validations.

● Configured SQA test use cases for SW security tokens on several Windows/Linux/RIM OS Platforms.

● Created Hardware testing fixtures and procedures for use in controlled test laboratory environments.

● Pre-screened & agency lab tested hardware security tokens for EMC, Safety, Shock, & HALT testing

● Accompanied prototype and manufacturing security tokens for third party CE/Mil-Std testing (NTS).

Sr. Test Engineer II/Lab Manager @ Abbott Diabetes Care : Bedford, MA [3/98 - 10/04]

○ Develops products to reduce the discomfort and inconvenience of blood glucose testing & monitoring ○

● Performed home and hospital glucose meter prototyping, quality testing, verifications, and validations.

● Created Medical Device electro-mechanical test fixtures & procedures for R&D, QA, Manufacturing.

● Pre-screened medical device prototypes for IEC 60601-1,EMC, FCC, & FDA 3^rd party agency testing.

● Hired and supervised senior electrical/mechanical R&D laboratory engineering Technicians, and aids.

● Maintained > 350 pieces of laboratory calibrated measurement equipment per ISO 17025 & FDA QSR.

EMC Test Systems Technician @ Chomerics Test Services : Woburn, MA [12/95 - 03/98]

○ Provider of global EMC & safety testing services and other comprehensive design capabilities ○

● Performed U.S. and European EMC testing (FCC, FDA, & CE) on electronic devices and test systems.

● Calibrated laboratory test equipment, created test fixtures, interpreted federal agency testing protocols.

● Interfaced with customers and their equipment in environmentally controlled laboratory test chambers.

● Holder of “SECRET” Dept. of Defense security clearance for testing military devices &sub-systems.

Senior R&D Technician @ Zoll Medical Corporation : Burlington MA [03/94 - 12/95]

○ Designs and manufactures products to encompass multiple facets of cardiac resuscitation ○

● Construction & test of prototype SMD circuitry and test fixtures for ambulatory defibrillator designs.

● Documented test results using MS WORD/EXCEL for engineering change and product design reviews.

● Accompanied medical device prototypes for agency testing to EMC (CE Mark) lab testing facilities.

Senior R&D Technician @ C.R. Bard. : Tewksbury/North Reading, MA [06/90 - 03/94]

○ Creates innovative medical products meeting healthcare providers and patients’ needs worldwide ○

● Developed SMD circuitry & system testing fixtures used for "In Vivo" blood gas monitoring devices.

● Performed metrics testing for fluid delivery of drug infusion pumps using precision weigh scales.

● Pre-screen tested and accompanied prototype and final products at EMC testing laboratory facilities.

● Maintained preventive maintenance/calibration logs for calibrated laboratory measurement devices.

Senior Electronics Test Technician @ ECRM Inc. : Tewksbury, MA [08/85 - 06/90]

○ Leader in developing imaging technologies for commercial graphic communications industries ○

● Test, diagnose, and repair of multi-layer analog and digital video processing PCB's to component level

● Performed optical alignments on high-resolution laser scanners & printers used in the graphics industry

● Utilized HEX-coded diagnostic programs for fault testing video processor PCBs and sub-systems.

Senior Test Technician / Supervisor @ Electronic Test Center : Littleton, MA [7/82 - 6/85]

○ Provides integrated circuit testing solutions for electronic device development companies ○

● Performed SSI/LSI/VLSI integrated circuit testing with hardware and software orientation.

● Responsible for ordering lab parts & supplies for the R&D & manufacturing test laboratories

● Supervision of laboratory integrated circuit testing personnel on the second shift (2/84 - 6/85).

EDUCATION AND TRAINING:

● Franklin Pierce College : Bachelor’s of Science in Computer Science – 12/02 [GPA: 3.5]

● Sylvania Technical School (now Wentworth Tech) : Computer Electronics - 2/84 [GPA: 3.5]

● National Instruments (LabWindows [CVI]) : Virtual Instrumentation training – 4/03

● National Instruments (LabView): Virtual Instrumentation application training – 7/04

● Kimmel-Gerke Associates: ESD/EMI training seminar for design engineering – 6/88

● View my profile on LinkedIn ► http://www.linkedin.com/in/mphenner

● Download an MS Word copy of resume’ here: PhennerResume.doc