Central Connecticut State University School of Business

United States Navy Electronic Technician School [SECURITY SYSTEMS]

University of New Haven

ASQ American Society of Quality

Rockville High School

FIELD SERVICE ENGINEER  -  ENGINEER TECHNICIAN  -  MEDICAL DEVICE SERVICE  -  ENGINEERING TECHNICIAN

Stealth Mode

Biomedical Engineer

Analyzed electronic-mechanical failures for medical device manufacturer’s new  System featuring neurostimulators and electrode leads. Oversaw Return Goods Authorization (RGA) product returns. Collaborated with operations, quality control, product monitoring, materials, customer service, engineering, and vendor liaison departments to investigate and solve problems. Inspected and tested explanted/returned products. Produced FDA technical failure analysis reports and placed findings into Enterprise Quality Management System (ETQ). Analyzed and checked documents to guarantee compliance with FDA regulations. 
Key Achievements:
	Taught eight-member manufacturing team and supervisor on updated ECO’ed work instructions plus conducted FDA quality audits and produced FDA required employee competency exams.
	Revamped decontamination test lab to ensure all operating equipment and laboratory procedures met and complied with OSHA regulations.
	Improved testing work flows by revising RGA CAGE (quarantine) including installing ElectroStatic Discharge Benches (ESD) in Anti-Static ESD-Safe area to protect valuable assets.
	Developed and wrote internal testing and troubleshooting FDA compliant work instruction manuals to repair, replace, and ship OEM supplied sub-components and assemblies.
	Helped decipher key EMI ElectroMagnetic Interference fault with wireless wands leading to wand redesign to eliminate problem.

NeuroPace

Medical Device Senior Failure Analysis 

Assisted with release of Johnson & Johnson’s new Calibra FinesseTM insulin patch-pen product. Undertook basic analysis test on completed items. Used standard test procedures and techniques to study material and component properties. Took part in n failure investigations and root cause analysis. Determined and supervised Finished Product Lab for Finesse Insulin Pump. Trained and coached new staff on equipment calibration methods and tests. Managed inventory, tracking, and reporting for controlled substances ($50K inventory). Directed factory tool calibration needs. Preserved equipment inventory and record keeping and reporting procedures. Established and monitored vendor on-site activities. Reviewed batch records. Tracked CAPA actions and change requests.
Key Achievements:
	Set and maintained consistent 100% calibration process ratings. 
	Validated Oracle’s Siebel Life Sciences (NorthStar) adverse event and compliance handling database. 
	Received Elite Gold Award for exceptional product analysis validation efforts.
	Promoted procedure to guarantee regulatory compliance with ISO 13485, improving and standardizing adverse event and compliance processes, enhancing accuracy in data capture, and initiating preventive actions. 
	Created various processes including safe syringe handling procedure, new test methods, improved inspections, and new strategies for qualifying finished product release test lab. 
	Implemented improvements connected to Finished Product Lab and Quality System. 
	Authored and executed cGMP test method validation protocols, final reports, work instructions, SOPs, and batch records to match dose accuracy system measurements.

Johnson & Johnson

Medical Device Engineer

Furnished 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 for optical biopsy medical device (Cellvizio). Conducted preventative maintenance tests, equipment calibrations, hardware integrations, staff trainings, troubleshooting, and repair. Arranged field safety acceptance tests meeting OSHA requirements and FDA validation tests. Monitored and sustained national warehouse in Chicago, IL. Aided sales team and clinical managers. 
Key Achievements:
	Trained in ISO 13485 (medical laser systems), IEC-60601-1 and HIPAA. 
	Honored for exceptional ability to correctly investigate and resolve issues and recommend solutions.
	Administered service activities and preventive maintenance testing for entire U.S. installed base.
	Implemented Key Preventive Maintenance Testing Schedule, which eliminated backlog of preventive maintenance testing in just six months. 
	Arranged customer visits aiding in 35% reduction in operating costs.
	Designed and wrote in-house factory procedures for product testing reducing hospital failures.
	Received employee recognition for consistently and effectively maintaining heavy field service schedule with no supervision.

Mauna Kea Technologies

Medical Device Field Service Engineer 

Handled technical issues for installing and maintaining automated FDA-regulated automated blood laboratory equipment in western United States. Taught customers about equipment operation. Suggested equipment design changes to development engineers. Provided round-the-clock emergency assistance at customer laboratories.  Served as primary liaison between customers and service organization. Managed region parts inventory.
Key Achievements:
	Analyzed and monitored performance on two advanced/prototype tube sorter model/options loaned to potential key/prime customer.
	Delivered detailed reports detailing specifications and enhanced system operations.
	Noted occurrences and locations of sporadic prototype option errors solving issue leading to improvements.

The m-u-t Group AG

Field Service Engineer 

Responded to urgent Priority 1 calls for non-functioning CT explosives detection systems. Fixed and reset airport bomb detection scanners. Prioritized other service requests to guarantee attention to critical needs. Held high-level government security clearance. Scheduled ongoing preventive maintenance on five high-value systems to ensure compliance with all directives.
Key Achievements:
	Simplified operations and dramatically improved organization of tool rooms, supply rooms, and offices.
	Developed and deployed multiple safety procedures avoiding serious injury or damage to complex, high-value equipment. 
	Addressed and resolved FAA and TSA issues to secure valuable contract extension.

Security Bomb Detection Field Service Engineer 

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 comprehensive ISO and FDA documentation. Trained new hires. 
Key Achievements:
	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.

Reliant-Technologies

Medical Device Service Engineer 

Senior Laser Engineer built, 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.

*** 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.

Newport Corporation - Spectra Physics Lasers

Laser Engineer 

Senior Optical Engineer provided critical contributions to launch of Alcon LADARwave Custom Cornea Wavefront medical device 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.

*** 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.

*** A joint venture between Carl Zeiss Meditec and Alcon Laboratories.

GARY PARKER