Michael Phenner

Exeter, NH 03833

(978) 273-5664

<mphenner@yahoo.com>

 

SUMMARY

Sr. Quality 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. Proven track record of consistently handling multiple task demands to high levels of competence & integrity … while 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 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

 

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

 

 

Sr. Quality Engineer: 11/09 – 3/11

● Created, maintained, & executed PCB and system level testing of new and existing ultrasonic products

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

● Performed risk assessments, troubleshooting & root cause analysis on electronic systems & components

 

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

Sr. 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, Wilmington, MA (IP purchased and relocated to NewYork):                               

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 & 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 - 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): Makes blood-glucose test systems

R&D 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 & safety agency certified test 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

Sr. 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 EN60601agency 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

Sr. 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]

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

Virtual Instrumentation Training Certificate - National Instruments (LabWindows [CVI])

Virtual Instrumentation Application Training Certificate - National Instruments (LabView)

EMC Training for Design Engineering Certificate -  Kimmel-Gerke Associates

Quality System Requirements and Industry Practice Certificate – A.A.M.I.

 

EXTERNAL LINKS:

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

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