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Candidate Info
years in workforce
years at this job
Electrical Engineering Technology
Forward Validation Engineer
Saved $20,000 over third party system by designing hardware and software for a custom vehicle bus emulator.
- Avoided $12,000 in capital expenditure by creating a custom, complex waveform generator system using embedded C, a microprocessor and a power op amp.
- Achieved cost avoidance of $3,000 per year, per user by implementing no cost version
- Reduced computer deployment labor costs by $2,000 per year by implementing standardized computer platform, drive imaging and cloning method.
- Specified, purchased, administered and maintained 50+ Windows XP lab computers.
Candidate Info
years in workforce
years at this job
Nuclear Medicine Technology
Lead Software Validation Engineer - Respiratory Solutions
Ownership for software verification and validation on a multi-functional team developing Puritan-Bennett's line of next generation Respiratory Care Products.
- Participated in design reviews finalizing designs which clarified and defined software requirements
- Provided hands-on design, development, and execution of software test plans and test protocols in accordance with defined development procedures in preparation for product V & V
- Updated and maintained 15 breath delivery protocols including traceability to requirements specification
- Mentored and leaded other test engineers and provides technical guidance as necessary during verification and validation activities
- Developed and maintained the Verification and Validation group's project schedules and roadmap ensuring project on schedule
- Ensured adherence to product specifications, industry standards, best practices, quality & regulatory procedures, and requirements to accurately test and release quality products
Candidate Info
years in workforce
years at this job
Criminal Justice
Industrial Technology
Computer Validation Engineer
Responsible for the validation and maintenance of production equipment, virtual applications, and network devices used in the development and production of pharmaceutical products.
- Authored in depth IQ/OQ/PQ protocols for electronic and mechanical devices in order to ensure complete validation in adherence to cGMP and 21 CFR 11 requirements
- Scheduled and maintained SQL backups, reviewed and verified security access to SQL databases, and validated data points for the plant's Facility Monitoring Service
- Responsible for the label design and database accuracy of packaging barcodes for the company and its OEMs
- Performed scheduled Periodic Reviews on mechanical and electronic laboratory and manufacturing devices to ensure that all devices operated as expected and were used in compliance with industry standards
- Created, revised, and updated control system SOPs in support of protocols, computer system changes, and departmental operations
- Performed routine system administration tasks on all process equipment systems and networks
Candidate Info
years in workforce
years at this job
Chemical Engineering
Pharmaceutical Manufacturing
Validation Engineer, Quality Assurance
Department lead for all validation activities including process, packaging, water, method, cleaning, and computer validations for presentation during FDA audits
- Redesigned and rewrote all procedures and documents for all validation activities, as well as performed plant wide training for both US and China plants
- Performed all pharmaceutical equipment qualification activities for an average of $3MM a year of processing, packaging equipment, and plant utility systems, including travel to international vendors and assisting our China plant
- QA lead for all new in-house product launches to ensure quality is maintained and specifications are appropriate and attainable
- Using tools such as statistical process control and design of experiments, implemented cost improvement studies across the entire plant
- Created universal packaging layouts for all nationwide plants
- Coordinated the fabrication, installation, and engineering of safety and production cost improvements on all corn chip ovens across the U.S.
- Collaborated in reviewing floor layouts of all U.S. plants in order to fit a new space saving project into product lines all over the country
Candidate Info
years in workforce
years at this job
Electrical And Computer Engineering Technology
Software Validation Engineer
Performed independent software validation on a range of RF products For Tier-1 Automotive Corp,
including: Chrysler, General Motors and Ford. Certified the functionality of Chrysler's Wireless Control Module
(WCM) and GM RFA/TX modules
- Analyzed requirements and transferred state diagrams to software requirements for software development and test case creation
- Managed a group of up to 10 people, by delegating tasks for various software releases and overseeing the documentation of results. Was the Project Lead for the mapping of Chrysler requirements against [company name]
- Increased the results proficiency of the Chrysler Diagnostics validation tests by 15% within the first 9 months.
- Directed contractors in creating new documents for future reference and testing
- Facilitated weekly international conference calls in order to manage project progress
- Analyzed signals between RFA and TX General Motors modules with Manchester coding
- Created and maintained the CMMI process documents in the configuration management system
Candidate Info
years in workforce
years at this job
Electrical Engineering
Onstar and Vehicle Connectivity Lead Validation Engineer
Developed and updated Test Procedures specific to over the air (OTA) communication with the vehicle (ie. Crash Notification, Diagnostics checks, Theft Notification, Advanced Diagnostic Access, Mobile Applications)
- Tested OnStar Module based on engineering specifications and change requests; Automated manual test procedures, increasing automated procedures from 10% to 80% in one year
- Acted as team CAN expert and trained team members on CAN bus and vehicle communication protocols
- Debugged software and test tool errors and assisted in finding solutions to complex problems
- Created and supported an OnStar Subsystem bench, which includes the Radio System (5 modules) and OnStar
- Contributed to engineering specification development
- Technical Lead for 2-3 Subsystem Test Engineers
Candidate Info
years in workforce
years at this job
Culinary Arts
Chemical Engineering
Chemistry
Validation Engineer
Established criteria for and participated in bi-annual media fills to ensure aseptic manufacturing techniques for an injectable product in the cleanroom environments during normal production.
- Established validation parameters for quarterly radiation audits and performed the radiation audits on product components per ISO and AAMI guidelines.
- Developed a cleaning validation master plan inclusive of cleaning techniques, testing methodology, analytical techniques, acceptance criteria based on current products and batch sizing, and a comprehensive schedule to ensure complete coverage of manufacturing equipment.
- Performed annual validation activities on all autoclaves and SIP (Steam in Place) cycles for critical processing equipment.
- Wrote, performed, and reviewed validation protocols and reports (IQ/OQ/PQ).
- Provided technical assistance with regard to validation issues to the process engineering department.
Candidate Info
years in workforce
years at this job
Business
Validation Engineer
Multimedia, component, and UI validation of multiple generations of Android phones and tablets
- Hardware and software troubleshooting including flashing Firmware images
- Created new test cases. Established test case sharing on the team
- Modeled well documented bug write-ups
- Repeated winner of the "Bug of the Week" award and entered the highest quantity of bugs
Candidate Info
years in workforce
years at this job
Mechanical Engineering Technology
Validation Engineer
Maintained test schedules for numerous locomotive orders for validation testing.
- Provided logistical and material support for testing at the Pueblo Colorado test track and customer property.
- Supported ongoing maintenance and modification of EMD test locomotives and cars.
- Supplied 2D and 3D plans and designs to group requirements.
- Involved in facility design, budgeting and interaction with the local railroad for test facility in Alabama.
- Assisted with test budgets for new model designs and upcoming projects.
- Work group representative for new product line meetings, as well as design and support meetings.
Candidate Info
years in workforce
years at this job
Communications Radiotelephone Operator License
Electronics Engineering
Validation Engineer
Created Development Test Plans for EcoWise 30 amp and 50 amp Power Saving Devices
- Created Development Test Plans for MotorWise 5 amp Motor Controller
- Performed Development and Validation testing on 30 amp and 50 amp Power Saving Devices
- Traveled to and Managed Validation Testing Lab activities in Mexico City
- Created and Managed ECN and PCN forms and processes
- Formated and reported Development Testing results and records
- Supervised on site installation and Alpha testing of product
Candidate Info
years in workforce
years at this job
Avionic Technology
Validation Engineer
- Implemented a software quality assurance plan and software validation SOP for mission critical systems, such as RSLogix 5/500, PanelBuilder 32/1400e, and document control software, to comply with 21 CFR Part 11.
- Initiated, performed and executed engineering studies, design of experiments, installation qualification, operation/process qualifications, corrective action activities and software validations.
- Lead programmers in the development of training and laboratory information management systems software.
- Specified, purchased, executed and validated $100,000 in laboratory instrumentation across a 1-year period.
Candidate Info
years in workforce
month at this job
Mechanical Engineering
Validation Engineer (contractor)
Provided validation expertise in the execution and support of the Mitizak Process project.
- Created and executed IOQ Protocols for Beckman Coulter Centrifuges.
- Executed IOPQ/IOQ Protocols for Stability Chambers and Moisture Analyzers.
- Met goals for the reduced timeline for Mitizak Process (Process Development).
- Performed Temperature Mapping on Stability Chambers and Incubators using Validator 2000.
- Prepared Final Reports for Beckman Coulter Centrifuges, Incubators, and Stability Chambers.
Candidate Info
years in workforce
years at this job
Psychology
Industrial Technology
Senior Verification & Validation Engineer
Team Lead for system software development/verification and validation group. Plan and allocate resources for multiple long-term medical device projects
- Developed testable system requirements. Analyzed requirements for testing purposes
- Write test plans, procedures, reports, traceability matrices, and review test results in accordance with company SOP governed by ISO 13485; Quality System Regulation 21, C.F.R. pt 820; IEC 62304
- Plan, lead, and perform formal Verification and Validation activities in support of 510(k) medical device/system FDA submission package
- Created and improved risk management/failure mode analysis
Candidate Info
years in workforce
year at this job
Mathematics
Electrical Engineering
System Validation Engineer
- Helped evaluate and test TI ADSL prototype designs to save company thousands of dollars and significantly reduce time to market.
- Tested software and hardware prototypes at industry interoperability test lab and at customer sites.
- Developed and implemented effective test procedures for ADSL chipsets to ensure rigorous compliance with ITU Standards G.992.1 and G.992.2, catching deficiencies in final software and hardware prototypes before they went to production.
- Tested and ensured compatibility with competitors’ G.992.1 and G.992.2 ADSL equipment and other telephony devices and data communications and security software.
- Presented test results to management and stakeholders through written and oral communications.
- Evaluated and recommended new test methods for new features for more effective deficiencies-catching and product development.
Candidate Info
years in workforce
years at this job
Engineering
Mechanical Engineering
Validation Engineer Contractor
Designed a cleaning cart in Solid Works to aid in the disassembly of QuikScale MAb columns during cleaning.
- Researched materials and processing requirements to outline functional and design specifications for a new autoclave.
- Purchased new flow meters used to monitor product flow through QuikScale MAb columns.
- Monitored and coordinated processing of experimental resin and worked with labs to sample and track the progress.
- Completed quality risk assessments and supporting documentation for the compressed air system in Manufacturing.
Candidate Info
years in workforce
months at this job
Electrical Engineering
Verification, Integration, and Validation Engineer
Designed and developed tests for products and systems based on engineering specifications.
- Aided product design engineers in debugging and failure analysis of products.
- Setup and configured test environment and system under test
- Preformed tests on integrated systems with customer application data.
- Aided suppler engineers with integration and testing.
- Developed test software for test data verification.
- Analyzed test result data and generated test documentation
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