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: CAPA, Training, Doc. Control, Calibration, Supply
Chain, Inspection, 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 (@ MIT- Bates) - Middleton,
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
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Covaris,
Inc. - Woburn, MA: Develops ultrasonic
instruments used in molecular-level R&D sample
preparation
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Sr. Quality Engineer:
11/09 – 3/11
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● 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 Assurance 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
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 military
devices 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 using MS 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
C.R. Bard Critical
Care and MedSystems
Divisions (later Baxter 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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