Michael Phenner

Exeter, NH 03833

(617) 816-5931

<michael@phenner.com>

SUMMARY

Senior Quality Engineer with management and hands-on 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, CAPA, Training, Doc. Control, Calibration, Complaints, 6-Sigma

  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 13385, FDA QSR, IEC 60601-1, EN 61326, 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

 

Covaris, Inc. - Woburn, MA:  Develops ultrasonic instruments for molecular-level CSI 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 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 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 (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 > http://phenner.com/LinkedIn References

- Resume’ Download link > http://phenner.com/MPhenner_resume