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Prod Testing/Verification &Validation testing. Environmental/ Stength

Martville, NY, 13111
September 13, 2018

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P.O. Box *** • Martville, NY **111 • 315-***-**** (M) •


Find a challenging Product Testing position in R&D, Sustaining, or Manufacturing Engineering utilizing my extensive experience.


30+ years’ experience with NPD - New Product Development, Production Engineering and Product Service support. Served in a multifaceted capacity blending extensive experience in all aspects of product testing activities merging the characteristics of a senior mechanical technician, lab manager, key team member and project/product contributor supporting multiple divisions and departments. Possess strong organizational skills, excellent work ethic, and extreme attention to detail. Solid track record of success in process improvements, demonstrated talent of unique problem solving skills, and a seasoned trainer of lab personnel on equipment and processes. Excellent presentation and people development skills.


ORTHO CLINICAL DIAGNOSTICS – Rochester NY 14626 May 2017 – Oct 2017

Software Engineer / Software Test Engineer for In Vitro blood Diagnostics

Support New Product testing and release of New SW versions for Immuno Diagnostics Blood Chemistry Analyzers / Automation Track System Testing. (Open Automation / EnGen Systems).

Support Mechanical testing of Upgrades / Enhancements / mods to systems. Solve complex problems and develop optimal performance requirements to prevent unanticipated failure modes and quality issues. Escalates concerns as appropriate.

Works independently. Partners with R&D, Operations, Quality, Regulatory, Compliance, and suppliers to ensure effective product development and knowledge transfer. Ensures compliance to Design Controls / Quality System requirements.

Provides Technical Input to Risk Management and Regulatory inspections. / Participates in CAPA activities, corrections to design related issues, and post-product launch failure investigations.

Directly support design change control activities with Suppliers / External Manufacturers. Review and approve plans / protocols / reports / deviations, and non-conformances. Document all changes through change control processes. Adheres to strict procedural / quality standards, thorough and accurate documentation, testing protocols.

ORTHO CLINICAL DIAGNOSTICS – Rochester NY 14626 June 2016 – Dec 2016

System Support Engineer – Field Service Engineer for In Vitro blood Diagnostics

Support Technical & Field Services Engineering Team to ensure product launch, service procedures, and logistics are in place for Immuno Diagnostics Blood Chemistry Analyzers / Automation Track System Testing. (Open Automation / EnGen Systems)

Provide SME - subject matter expertise input into service procedures / code recovery. Provide Reliability information to design teams for current product performance, Drive serviceability of reliability initiatives / critical diagnostic tools for new products.

Develop Service Documentation for FE-Field Engineers. Develop spare parts strategy, modification, development and deployment of system upgrades, Create standardization of repair processes, troubleshooting guides. Develop new diagnostic tools to drive Field and technical support Center efficiencies.

Provide project management oversight and support for cross-functional projects between IT, Finance, R&D and Operations.



Management of all aspects of The Reliability Lab to include but not limited to the following:

Development and Execution of Verification and Validation Test Plans for PPL - Present Product Line, NPD - New Product Development, NG - Next Generation Improvements and Enhancements for Hemodialysis Vascular Access products, Research, Critical Care, and Bioprocess products.

Multiple role support of teams from Project planning-Concept to Release / Product Design Reviews / Design Transfer to Manufacturing, Development of WI - Work Instructions, Tooling / Fixturing and Training, Product Manuals, Product literature, Post Market Surveillance, Demo Product and Displays.

Lab Design Layout and Facilities usage, Equipment acquisitions for all product testing.

Management of Lab Technicians, Training, Test Scheduling.

Support to R&D Engineering / Engineering / Manufacturing / Marketing for all product Performance issues, Experimental Tests, Baselines Tests, Prototype construction, and Failure analysis.

Development of Standardized Test Templates for Test Requests, Test Reports, Management of Test Report Database.

TRANSONIC SYSTEMS INC. – Ithaca NY 14850 March 2009 –May 2009


Adherence to TSI QMS - Quality Management System / Quality Metrics / Internal Audits / Resolve Daily quality issues.

Assist with Development, implementation and administering of Quality Specifications, Test methodologies across product lines.

Standardize Formats to improvements for WI & Controlled Documentation.

Vendor Certification & CA Corrective Action resolution.

MRB – Material Review Board for disposition of damaged or defective components, assemblies for both internal and external sources. (NCMR – Non Conforming Material report)

Manage Incoming Inspection of product / components, Training of inspection personnel.

Manage Equipment Calibration Database.

GE – INSPECTION SYSTEMS DIVISION, Skaneateles NY. March 2008 –December 2008


Primary role to provide technical support across Production Clean Room / manufacturing facility, ensuring efficient and high quality production of existing and new products.

Development and implementation of new or improved manufacturing processes, trouble shooting of product line processes at subassembly, final assembly and full system levels. Complete Root Cause Analysis / Failure mode and CA – Corrective Actions to full implementation.

Train manufacturing technicians and operators on new and existing assembly, test procedures and equipment.

Perform PM - preventative maintenance and calibrations on process equipment and tooling including repair / replacement and upgrades to increase efficiency.



Development and implementation of test protocols and testing to satisfy all aspects NPD – New Product Development / NPI – New Product Introductions including, but not limited to:

Mechanical Tests, Chemical / Material Compatibility Tests

Reliability – Life Cycle Tests. Design and build cycle test machines to simulate life of product functionality.

Environmental Tests – All Extreme Temp (hot / cold) / Temp & Humidity tests / Thermal Shock

Materials Strength Testing - Using Lloyd LR10K / MTS Force Works Tensile Test Machines / Mark 10 Force & Torque Equipment

Shipping Tests - ISTA 1A / 2A etc. Including Packaging design and development

Biocompatibility tests – LLD / HLD / Cold sterilization / Steam sterilization / Hydrogen Peroxide

Optical Testing - measurements to confirm functionality for Magnification, Distortion, Field of view( FOV ), Resolution Capability, Pupil sensitivity, Diopter correction, Light transmission. etc.

All phases of assembly from prototype builds to full production units. Custom modifications to assemblies, initial gate build verification, marketing / ergonomic prototypes, Full Verification / Validation testing of production runs.

Product Line Cost Reductions for assembly, tooling, process.

Trouble shooting component, process, tooling, assembly procedures to Determine Failure Mode, Corrective Action to optimize production productivity, and increase throughput.

Medical Research &Development Lab:

Design and successive Redesign of the R&D lab, Chem. Lab, Optical lab, Cycle test labs as lab requirements and space changed, to make labs more efficient and useful for all employees.

Management of the State Street Facility Chemical Laboratory 1989 – 2002

Train new hires (permanent employees, engineers, techs, engineering student co-ops) on chemical lab usage, chemical testing / material compatibility testing, chemical safety.

Ordering / inventory management of Chemical Lab supplies / expendables. Disposal of waste chemicals.

Management of the Environmental Chamber Laboratory

State Street Facility 1989-2008 / Jordan Road Facility 2003-2008.

Train all new hires (permanent employees, engineers, techs, engineering student co-ops) on chamber usage, lab usage, chamber testing, thermal profiling, and chamber programming.

Schedule all chamber usage thru custom designed lotus notes database. Coordinate testing schedules with chamber availabilities vs. testing requirements, project priorities, and project groups, including offsite divisions Everest VIT (EVIT ), Hand Help Products ( HHP ),WA Germany / WA Ireland / WA California.

Maintain clean, service and repair all environmental chambers as needed to prevent costly downtime of offsite service. Single repairs save approximately $1,000 each. Approximately $30,000 savings per year.

Coordinate service with provider to optimize repair time and alternate sources for testing. Coordinate and schedule all yearly calibrations and PM Service for all environmental chambers.

Design & implement upgrades to lab for AC system, water filtration system, lighting, computer drops, and electrical requirements for chambers and all auxiliary equipment required for testing.

Coordinate upgrades to chamber lab for new chamber purchases, chamber upgrades (low ultra, low humidity systems) custom doors and access panels, etc. Increased the capability of the chamber lab initially from 2 bench top chambers to total of 16 environmental chambers in excess of $300,000.

Force Testing- Material Strength Testing:

Train all new hires (permanent employees, engineers, techs, engineering student co-ops) on machine usage, set-up, testing and evaluation of failure modes for all components, subassemblies, full assemblies, mechanism, etc.

Complete machine repairs and order additional components and load cells, machine upgrades, etc.

Specify new purchases for all hand held devices, force gauges, torque gauges, stands, auxiliary equipment, and new force test machines. Schedule, coordinate yearly calibration and PM of force testing machines.

Design, build, and fabricate modular plug and play fixturing for testing purposes, reducing the need to remake fixturing each time for additional testing. Design and develop custom fixturing to satisfy specific testing needs.

Program force test machine functions to specifics required for testing. Utilize force test machine as a precision cycle test machine for very critical testing.


Presidential Beacon award for exemplary service - 2001 – Welch Allyn Skaneateles N.Y.

200+ Level 1 / Level II recognition awards – Welch Allyn Skaneateles N.Y.

US Patent no. D520, 464 – Illuminator switch assembly– Welch Allyn Skaneateles N.Y.


Bachelors Degree - Biological Science - Syracuse University 1984

AAMI Design Controls and Industry Practice Certification - Welch Allyn, Skaneateles N.Y.

ISO 9000 Quality Assurance Testing - Welch Allyn, Skaneateles N.Y.

Cadra Design software - Welch Allyn, Skaneateles N.Y.


Founding member the 1st self-directed work for Welch Allyn / Member of Medical R&D Lab Committee 1989 – 2003

Self-motivated, extremely team oriented. Well versed in coordinating and working between cross functional groups from R&D / Production engineering / Tech Services- Repair / Marketing

Trained all new hires – engineers, techs, co-ops on environmental chamber usage / chamber programming, Lloyd LR10K / MTS Force Works Machine, Chem. lab safety & usage, Cycle Test Design


Video Endoscope Repair Facility - Along with fellow Engineer traveled to Guangzhou China to set up Video Endoscope Repair Facility. We redesigned their lab, set up their decontamination / disinfection / sterilization system and trained engineers and technicians how to repair all aspects of our video scope products / hand held products.

Facility improvements included how to optimize staff and equipment to run the repair facility efficiently, Including but not limited to logging in returned product, setting up stock, supplies, repair documentation, test protocols, warranty – service calls etc. Everything that was needed to become a partner in quality supporting corporate objectives.

Computer Skills: Word, Excel, Lab view

Additional information and references: Available upon request

Contact this candidate