SUMMARY:

Sr. Quality & Systems Test Engineer with hands-on experience in electronic medical device testing in secured laboratories. Highly motivated team individual with excellent organization, communication, & technical problem solving skills. Proved track record of consistently handling multiple task demands to high levels of competence and integrity, while also meeting critical deadlines in minimally supervised environments. Areas of expertise include:

 

Quality Systems: Supply Chain, Inspection, CAPA, Training, Doc. Control, Calibration, Complaints, 6-Sigma

Medical device test development, risk assessment, verification, validation, & reliability tests (R&D & MFG)

Author ECOs, FMEAs, IQ/OQ/PQ, test procedures, test cases per GMP, FDA QSR and ISO 9001/13485

Electro-mechanical medical device assessment and testing per ISO14971, FDA, IEC60601-1, EN 61326

Manage/qualify electronic laboratory test equipment per ISO17025, ISO14971, & FDA QSR (21CFR:820)

Diagnose, and repair complex electronic SMD/Through-hole circuitry, and systems to component level

EQUIPMENT: O-Scopes, Logic/Spectrum Analyzers, Emulators, Simulators, DMMs, Laser Optic Vibrometers

OS/SW/APPS: MiniTab (for statistical analysis), Win(all), C, Unix, LabVIEW, Test Director, HTML, MS Office

PROFESSIONAL EXPERIENCE:

ProTom International - Wakefield, MA: Develops accelerated proton beam therapy devices

Sr. Quality Engineer: 4/11 - Present

Create validation protocols, perform inspections and/or tests, analyze results & prepare summary reports

Document assembly, test, labeling, packaging, delivery, setup, installation, and servicing processes.

Audit suppliers and their quality system processes using FDA 21 CFR 820 and ISO 13485 requirements

Provide contributions to regulatory filings and to the Corrective and Preventive Action (CAPA) processes

 

Covaris, Inc. - Woburn, MA: Develops ultrasonic instruments for molecular-level R&D sample preparation

 

 

Sr. Quality Engineer: 11/09 3/11

● Create, maintain, and execute PCB and system level testing of new and existing ultrasonic products

● Author engineering design change orders for medical device products and controlled documentation
● Develop PCA and system level calibration and setup procedures for engineering and manufacturing
● Carry out investigatory testing, inspections, and vendor qualifications as QA MRB committee member

● Risk assessment, troubleshooting, & root cause analysis on electronic systems, PCBs, & components

 

ESA Biosciences (now Dionex), Chelmsford, MA: Develops liquid chromatography [HPLC] systems

Quality Engineer: 4/08 7/09

● Assisted in new product designs incl. risk assessment, design verification & validation testing (R&D & Mfg)

● Authored & managed ECOs, calibration, training, complaints, CAPA systems, & database tracking S.W.

● Mitigated vendor defects through supplier corrective action processes as QA MRB committee member

● Maintained Quality System in accordance with ISO13485, ISO9001, ISO17025, FDA QSR (21CFR:820)

● Performed internal/external supplier audits to assess Quality System compliance & improvement areas

 

OmniSonics Medical Technolgies, Wilmington, MA (IP purchased & relocated to NY):                                 

Start-up developer of catheter-based ultrasonic technology to treat Peripheral Vascular Occlusive disease

Sr. Quality Engineer: 12/05 - 11/07

● Created DFM test fixtures, procedures, & reports for electromechanical intravascular ultrasound devices

● Performed Class III medical device prototyping, EN60601-2 compliance testing, Life tests, & validations

● Performed design verification, validation, risk analysis, and EMC testing for QA, R&D and manufacturing

● Managed engineering lab personnel, clean rooms, & performed equipment qualifications (IQ/OQ/PQ)

● Reduced open issues by 75% as Manager of the Corrective And Preventative Action (CAPA) committee

 

RSA Security (Division of EMC),Bedford, MA: Provider of cryptography and data security devices

Quality Engineer (Consultant) - 10/04 - 7/05

● Wrote & Performed QA test cases for embedded SW security tokens on Windows & Linux platforms

● Performed hardware and software based security identity token testing, verifications, and validations

● Created & qualified testing fixtures and equipment for use in controlled test laboratory environments

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

 

Abbott Diabetes Care (was MediSense) - Bedford, MA (relocated to CA): Creates blood-glucose test systems

R&D Test Engineer II / R&D Lab Manager: 3/98 - 10/04

● Developed medical device testing fixtures, procedures, and V&VS for R&D, QA, & MFG per ISO 13485

● Pre-screened SW embedded medical device prototypes and DFMs for IEC 60601-1, FCC, FDA, and UL

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

● Managed R&D E.E., M.E. (Model shop), and environmental chamber laboratories (& associated equipment).

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

 

Parker Chomerics, Woburn, MA: Provider of global EMC and safety agency certified testing services

Electromagnetic Compatibility Systems Test Engineer: 12/95 - 3/98

● Led U.S. & European agency CE testing on electronic devices & systems per EN60601-1, EN50082, FCC

● Calibrated/qualified laboratory test equipment, test fixtures via federal agency test protocol interpretation

Interfaced with customers & equipment in EMC and environmentally controlled laboratory test chambers

● Hold SECRET Dept. of Defense security clearance for testing militarydevices and their control systems

 

Zoll Medical Corporation, Burlington MA: Manufactures external & internal cardiac defibrillator systems

Senior R&D Technician: 3/94 - 12/95

Constructed and tested prototype circuitry and qualification of test equipment for defibrillator designs

● Documented test results usingMS WORD/EXCEL for engineering change & product design reviews

● Performed PCBA and system-level QA testing on prototype and production defibrillator instruments

● Brought defibrillator prototypes & finished products for EN60601-1 agency testing to 3rd party test sites

 

Bard Critical Care andMedSystems Divisions(laterBaxter Healthcare) Tewksbury, N. Reading, MA:

International developer of hospital and home medical devices and innovative biotechnologies

Senior R&D Technician: 6/90 - 3/94

●Created test circuitry and fixtures for in fiber-optic catheter-based blood-gas monitoring devices

● Developed prototype circuitry and testing fixtures used for hospital room IV drug infusion pumps

●Interfaced with test equipment (via RS232, IEEE488) and other PC based data acquisition boards

● Pre-screen tested and accompanied prototypes/final products at EMC (CE Mark) testing facilities

 

EDUCATION AND TRAINING:

Bachelor of Science in Computer Science: Franklin Pierce College, Rindge, NH [GPA: 3.5]

Diploma Sylvania Technical School (now Wentworth Tech) : Computer Electronics - [GPA: 3.5]

National Instruments (LabWindows [CVI]): Virtual Instrumentation training

National Instruments (LabView & CVI): Virtual Instrumentation application training

Kimmel-Gerke Associates: ESD/EMI training seminar for design engineering

 

EXTERNAL LINKS:

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

View my LinkedIn Recommendations http://phenner.com/LinkedIn_References.htm

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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