GARY PARKER 338 Deanne Lane, Daly City, CA 94014 | 650-731-4004

cGMP@GaryParker.net | linkedin.com/in/gary-parker-61412322

TECHNICIANVersatile professional with extensive experience installing, testing, configuring and repairing electronic medical equipment, systems, and critical biomedical instrumentation.Proficient in analysis and testing of electronic systems and circuits at the component level, while supporting installation of electronic sub-assemblies, and modifying electronic devices to meet the unique needs of each project. Adept at reading and translating complex blueprints, schematics, and product manuals to ensure calibration, testing and maintenance of medical instrumentation adheres with FDA and OSHA regulations. Excel at collaborating across departments with staff and managers to complete projects on time and within budget. Core Skills include:

Equipment Modification & RepairVendor Liaison and CoordinationFull Lifecycle Project ManagementTroubleshooting & Problem ResolutionISO 9000 | ISO 9001 | ISO 13485 Technical Documentation Generation

Failure Analysis & Fault Detection Strategies New Technologies ImplementationCross-Functional - Platform TeamsInventory Control | Parts ManagementManaging Biohazard | Clean Room OperationsHIPPA Regulations

Technical expertise includes… Applicatio

nsOracle Database Systems, ASK, Reflection for HP, PeopleSoft, SAP, ETQ Quality Management Software, IFS ERP Enterprise Software, MS Office (Word, Excel, Access, Outlook), Windows, UNIX, MAC

Systems Endoscopes, CT-SCAN's, Medical Laser, Blood Laboratory Automation Equipment, Lasik Plus

Equipment Photo Diode, Power Supply, X-ray Equipment, Hi-Pot Test, EE-Prom BurnerTools Beam Profiler, Caliper, Chart Recorder, Densitometer, Digital Multi-meter, DVM, RF

Meter, Environmental Chamber, Hand Held Tools, Heavy Duty Winch, Instron, Laboratory Equipment, Micrometer, Microscope, Particle Counter, Power Meter, Optical Viewer, Oscilloscope, Radiation Meter, Signal Generator, Soldering, Test Equipment, Thermal Meter, Voltmeter

EXPERIENCE HIGHLIGHTSNEUROPACE, INC., Mountain View, CASenior Failure Analysis Technician, 12/2014 – 12/2016Recruited by this leading Medical Device Manufacturer to perform electronic-mechanical failure analysis on the firms new RNS® System, including neurostimulators and electrode leads. Managed all Return Goods Authorization (RGA) product returns. Worked closely with Operations, Quality Control, Product Monitoring, Materials, Customer Service, Engineering and Vendor Liaison teams to resolve issues. Conducted inspection and testing on explanted/returned products. Prepared FDA technical failure analysis reports and entered recommendations into Enterprise Quality Management System (ETQ). Reviewed and verified documentation to ensure compliance with OSHA regulations. Laid off - lack of work.

GARY PARKER

Trained eight-member manufacturing team and supervisor regarding revised ECO’d test and troubleshoot work instructions, conducted FDA Quality Audits and produced FDA employee competency exams.Credited for overhauling Decontamination Test Laboratory to ensure all operating equipment and laboratory procedures met and complied with OSHA regulations.Credited for improving testing work flows by overhauling the RGA CAGE (quarantine), including installing ElectroStatic Discharge Benches (ESD) - Anti-Static ESD-Safe area to protect valuable componentsConceived, developed, and authored in-house testing and troubleshooting FDA Compliant Work Instruction manual for repairing, replacing and shipping OEM supplied sub-components and assemblies.Played key role in identifying critical EMI ElectroMagnetic Interference fault with the wireless wands that led to the redesign of the wand to eliminate the fault.

CALIBRA MEDICAL, A DIVISION OF JOHNSON AND JOHNSON, Redwood City, CAContract Test Technician, 1/2014 – 5/2014Selected to serve as sole technician to support the release of Johnson & Johnson’s new Calibra FinesseTM insulin patch-pen product. Performed sample analysis testing on finished products. Utilized standard test procedures and techniques to evaluate properties of materials and components. Participated in failure investigations and root cause analysis. Established and managed Finished Product Lab for Finesse Insulin Pump. Oversaw inventory, tracking, and reporting for controlled substances ($50K inventory). Coordinated factory tool calibration requirements; maintained equipment inventory and record-keeping / reporting processes. Tracked and scheduled vendor on-site activities. Performed batch record reviews. Monitored CAPA actions and change requests. Trained and mentored new team members on equipment calibration methods, and tests. Laid off - contract assignment ended.

Consistently achieved and sustained 100% rating on calibration processes. Validated Oracle’s Siebel Life Sciences (NorthStar) adverse event and compliance handling database. Won the Elite Gold Award in recognition for exceptional product analysis validation efforts. Drove process to ensure regulatory compliance with ISO 13485; improved / standardized adverse event and compliance processes, enhanced accuracy in data capture, and initiated preventive actions. Developed multiple processes including a safe syringe handling procedure, new test methods, improved inspections, and new strategies for qualifying a finished product release test lab. Implemented improvements associated with the Finished Product Lab and Quality System. Wrote and implemented cGMP test method validation protocols, final reports, work instructions, SOPs, and batch records to meet dose accuracy system measurements.

MAUNA KEA TECHNOLOGIES, South San Francisco, CAField Service Engineer, 8/2012 – 10/2013 Served as sole US Field Service Engineer for optical biopsy medical device (Cellvizio). Provided expert onsite technical support for 105 medical laser systems at hospitals across 48 states, including NCI Cancer Centers, national military medical bases, Veterans Administration hospitals, and other leading institutions. Performed preventative maintenance tests, equipment calibration, hardware integration, staff training, troubleshooting and repair. Orchestrated field safety acceptance testing in accordance with OSHA requirements and FDA validation testing. Additional responsibilities included regular monitoring and maintenance at the national warehouse located in Chicago. Supported the Sales department and Clinical Managers. Laid off - company relocated from California to Georgia.

Fully trained in ISO 13485 (medical laser systems), IEC-60601-1; HIPAA trained and certified.

GARY PARKER

Recognized for exceptional ability to accurately identify and trouble shoot issues, and propose solutions. Oversaw service activities and preventive maintenance testing for entire US installed base.Implemented Key Preventive Maintenance Testing Schedule, which completely eliminated backlog of preventive maintenance testing in just six months. Strategically planned customer visits, contributing to 35% reduction in operating costs.Developed and wrote in-house factory procedures for product testing, thus reducing hospital failures.Received employee recognition for consistently and effectively maintaining a heavy field service schedule with no supervision. Maintained flexibility to coordinate with HQ in France as required.

M-U-T AMERICA, South San Francisco, CA Contract Field Service Representative, 8/2010 – 4/2011Served as sole technical representative in the Western US for installation and maintenance of automated FDA-regulated automated blood laboratory equipment for this start-up company. Trained customer personnel on equipment operation. Provided development engineers with feedback and follow-up to support design changes or modifications to equipment. On-call 24/7 for emergency needs at customer laboratories. Served as primary interface between customers and the Service organization. Maintained parts inventory for entire region. Laid off – contract assignment ended.

Provided extensive analysis and performance monitoring on two advanced/prototype tube sorter model/options on loan to a potential key/prime customer. Laid off - contract assignment ended.Delivered detailed reporting to refine specifications and enhance system operations.Creatively used iPhone movie capabilities to capture occurrences and exact locations of intermittent errors on prototype options, solving a question that led to improvements.

GENERAL ELECTRIC HOMELAND PROTECTION, INC., San Francisco, CAContract Field Service Engineer, 10/2008 – 4/2009Provided rapid response to Urgent Priority 1 calls for non-functioning CT explosives detection systems. Repaired and requalified airport bomb detection scanners. Prioritized other service requests to ensure attention to critical needs. Maintained high level government security clearance. Coordinated regular preventive maintenance on five high-value systems to ensure systems complied with all directives. Laid off – contract assignment ended.

Streamlined operations and dramatically improved organization of tool rooms, supply rooms, and offices.Devised and implemented numerous safety procedures that prevented serious injury or damage to complex, high-value equipment. Instrumental in addressing and resolving FAA and TSA issues for GE to earn valuable contract extension.

RELIANT-TECHNOLOGIES, INC., Mountain View, CACustomer Service Technician, 6/2007 – 5/2008

Played key role in managing the upgrade initiative involving Fraxel medical laser equipment. Oversaw tear down, re-test, re-assembly, and troubleshooting of electrical, mechanical, and optical systems. Prepared international upgrade kits for assembly and test by foreign contractors. Held accountability for testing and repair on defective equipment. Maintained

GARY PARKER

comprehensive ISO and FDA documentation. Trained new hires. Laid off - company folded after failed IPO.Reorganized and overhauled storage customer service areas, increased safety, and productivity.Contributed to resolution of a fatal error affecting more than 50% of systems.Recognized by management for exceeding customer upgrade commitments each quarter.Credited for saving $200K in product costs by changing Bill of Materials practices and procedures.

SPECTRA-PHYSICS LASERS, MOUNTAIN VIEW, CASenior Test Technician, 1/2004 – 1/2007Built, aligned, tested, calibrated and troubleshot Q-switched pulsed lasers and CW continuous wave lasers. Conducted comprehensive company-wide Internal ISO Audits, Laser Safety Audits, General Safety Audits, and Cleanroom Housekeeping Audits. Laid off – company-wide downsizing.

Overhauled two Manufacturing Engineering supply rooms, rectifying serious safety issues.Consistently stayed ahead of manufacturing time standards.Earned Certified Quality Auditor certificate following 10-week program of study.

CARL ZEISS MEDITEC - ALCON LABS (JOINT VENTURE), DUBLIN, CASenior Test Technician, 7/2002 – 10/2003Provided critical contributions to launch of Alcon LADARwave Custom Cornea Wavefront system, which makes detailed measurements of aberrations in the human eye. Independently integrated complex optical-electrical instrumentation, working from engineering drawings and specifications. Components included precision optical system and supporting electronics. Laid off – end of production run – lack of work.

Trained and certified assemblers and technicians on test and assembly procedures within Demand Flow Technology Manufacturing environment.Ensured full compliance with ISO, FDA, and cGMP procedures.Appointed Manufacturing Floor Auditor.Identified source of contaminations on critical optics, removing obstacle to schedule.Relocated during final launch phase to customer facility in Orlando, FL, providing close attention that was instrumental in achieving successful early product introduction.

CUTERA MEDICAL, BRISBANE, CAContract Senior Manufacturing Engineering Test Technician, 5/2001 – 5/2002Performed extensive product testing, repair, and quality inspection of high-power electro-optical medical laser system. Operated specialized machinery to evaluate and test power supplies, maintained extensive test report data using electronic database, and developed troubleshooting resolutions for product performance and manufacturing development. Laid off – contract assignment ended.

Performed extensive product testing, repair, and quality inspection of high-power electro-optical medical laser system. Operated specialized machinery to evaluate and test power supplies, maintained extensive test report data using electronic database, and developed troubleshooting resolutions for product performance and manufacturing development.Assembly, final test, alignment, and troubleshooting of complex medical device laser optical systems.Spearheaded investigation to identify root cause of water leaks occurring near high voltage electronic components, which resulted in improved assembly production procedures.Accurately indicated unsafe housekeeping and operational processes, and provided

GARY PARKER

comprehensive recommendations to improve laboratory cleanliness and safety.

KODAK-LUMISYS MEDICAL IMAGING, SUNNYVALE, CALead Manufacturing - Quality Assurance Technician, 5/1990 – 2/2001Directed group of 8 Senior Manufacturing Personnel to coordinate production of electronic, mechanical, laser, and optical medical device systems. Delegated daily work assignments, participated in operational meetings, and administered human resources functions, including preparing annual performance review, coordinating payroll authorization, and interviewing and hiring procedures. Conducted final quality assurance tests to ensure production standards, maintained extensive device history records, and participated in development, implementation, and evaluation of quality systems, procedures, and controls. Laid off - company relocated from California to New York.

Supervised the assembly of electro-mechanical optical systems within an assembly group of eight (8) people; this included top level assemblies as well as sub-assemblies including PCB rework.Ensured production quality standards were met in the manufacture and assembly of the LumiScan x-ray film digitizer.Conducted quality assurance final test on a family of precision digitizers that converted medical images on film into digital format.Assisted in the development, implementation and evaluation of quality systems, procedures and controls.In process inspection, final test, alignment, and troubleshooting of complex medical device laser optical systems.Produced revised versions of written guidelines for quality assurance testing, manufacturing testing, and manufacturing assembly procedures.Served as sole Manufacturing Test Technician for building and testing of electronic-optical laser plate assemblies.Formally recognized for exceptional work performance by Director of Operations for successfully assuming responsibilities of Manufacturing Supervisor by maintaining department productivity and encouraging team cohesiveness.Utilized product manufacturing and procedural expertise to provide training for all new hires and direct cross-training of existing technicians. Received increasingly responsible promotion to Lead Technician.

EDUCATION & CREDENTIALS

Advanced Electronic Technician - US NAVY ADVANCED ELECTRONICS SCHOOL, Great Lakes, ILBS in Business Administration - CENTRAL CONNECTICUT STATE UNIVERSITY, New Britain, CTProfessional Development− Certified Quality Auditor - American Society for Quality (ASQ)− Continuous Improvement Associate - American Society for Quality (ASQ)− HIPAA trained and certified− Biohazards training

GARY PARKER

SPECIALITIES

Biohazards, Calibration, Capital Equipment, cGMP, Clean Rooms, Credentialing, Customer Service, Decontamination, Development, Device History Records, DHR, Digital Imaging, Electronics Repair, Electronics Engineering, Equipment Installation, Engineering, FDA, Field Service Engineering, Field Service Engineer, Field Service Technician, GMP Hardware Diagnostics, Hospitals, ISO 9000, ISO 13485, HIPAA, Medical Device, Product Support, Repair, Research, Safety, Technical Writing, Technical Support, Technical Documentation, Troubleshooting.