Michael Phenner
Dover, NH 03820 (617) 816-5931 <michael@phenner.com> SUMMARY
Senior Quality Engineer with hands-on and management experience in electronic
medical device development and validation in secured laboratories. Motivated team
player with excellent organization, communication, & technical problem
solving skills. Proved track record of consistently handling multiple tasks
to high levels of competence and integrity, while also meeting critical
deadlines in minimally supervised environments. My areas of expertise
include: ● Quality Systems: Supply Chain, Inspection,
Audits, NCR, CAPA, Training, Doc Control, Calibration, Complaints ● Medical device test development, risk
assessment, verification, validation, and reliability tests (R&D &
MFG) ● Author DCNs, ECOs, FMEAs, IQ/OQ/PQ, test procedures, test cases per GMP, FDA QSR and ISO
9001/13485 ● Medical device assessment & testing per
ISO 14971, ISO 13485, FDA 21CFR820,, IEC 60601-1, IEC 62304 ● Manage/qualify electronic laboratory test
equipment per ISO 17025, ISO 14971 and FDA QSR (21CFR:820) ● Troubleshoot and repair complex electronic
SMD/Through-hole circuitry and systems to the 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 for hospitals Sr.
Quality Engineer: 4/11 - Present ● Document SOP, WI, assembly, test, labeling,
packaging, setup, installation, PM & servicing processes. ● Performs risk analysis for all phases of product life
cycle (concept, design, process, post-market). ● Audits suppliers and their quality system
processes using FDA 21 CFR 820 and ISO 13485 requirements ● Contributes to regulatory filings, NCRs and the
company’s Corrective & Preventive Action system ● Generates graphs & charts to trend/evaluate
effectiveness of the quality system for management reviews. ●
Performs Document Control operations as backup (via PTC Integrity, Arena,
Oracle) and internal audits
● 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 ● 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 and 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
test fixtures, procedures, and reports for catheter-based intravascular ultrasound
ablation 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 & authored/performed medical 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 (moved to CA):
Makes 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
(& assoc. 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 EMC testing
on electronic devices/ systems per FDA, EN60601, EN50081/82 QSRs ● 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
● Held “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 PCB and system-level
bench testing on prototype and production defibrillator instruments ● Accompanied defibrillator
prototypes & finished products for 60601 agency testing to 3rd
party test sites CR Bard: Critical Care & MedSystems (later Baxter Healthcare) Divisions – Tewksbury; N. Reading,
MA: International developer of hospital and home medical devices .. and other 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] A.A.M.I.: Quality System Requirements and
Industry Practice” training certificate American Society for Quality (ASQ): Full membership since
2004 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
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