Kyle Stanton

Chief Engineer - Project Manager

adb8sn@r.postjobfree.com

Mobile: 602-***-****

References: LinkedIn

Summary:

Motivated multi-discipline technical project manager/engineer with experience in working in fast paced globally diverse highly regulated environments. Looking to expand current market impact/opportunities by taking on an engineering/management role within a consulting firm or larger company. Proven ability to seek out and eliminate inefficiencies, identify and capture profit opportunities, and influence change within large globally diverse corporations. Core Competencies:

Customer service, project management, total product life cycle management, engineering design and management, product development, data collection, regulatory compliance, ISO 13485 lead auditor, and report/whitepaper generation.

Secret Clearance Active

Work Experience:

Nov 2010 – Jan Current Titus Innovations. Reno, NV President/Chief Consultant

Small Consulting Company specializing in technical project management/recovery and engineering design. Specific interest in medical military and aerospace applications. We focus on working inside of highly regulated markets and expanding new internal tools and capabilities where a demand for compliant products exists.

- Systems Engineer Compliance Lead for Sierra Nevada Corporation Nov 2019 – Dec 2019 Responsible for establishing ISO 13485 compliant processes and tool sets for the manufacture of Class II medical devices. Updated existing AS9100 compliant processes and modified where required to comply with ISO 13485, IEC 62304, and ISO 14791 standards. Introduced new audit administration, data collection, and compliance tool sets as required across functional teams.

- Chief Engineer/Weapon Systems for On Point Defense Technologies April 2018 – Jan 2020 Responsible for the design and integration of the Under Armor TOW concept designed to bring Bradley like capabilities to light tactical wheeled vehicles. Performed and supervised all Military Standard Qualification of next generation Armament Control Unit (ACU)

- Chief Engineer/ Business Consultant for Agile Radio March 2015-Dec 2019 Management and Business Development: Maintain principal and Investor relationships through regular meetings and program reviews. Developed technology development and business/investment plan to resurrect 220-222Mhz private spectrum band through the use of software definable radios connected over internet infrastructure for voice and IoT applications. Product Design and Project Management: Managed and actively lead technical development team to deliver new software defined radio capability. Completed several proof of concept/prototype designs for testing in preparation for final FCC type certification in Nov 2016. On track for final delivery.

- FDA Process and Test Compliance Consultant for Dexcom April 2017-Dec 2017 Developed and released processes and protocols for FDA 21 CFR 820 product compliance related to the final manufacturing and release of Dexcom’s G7, Firefly, and Gemini blood glucose monitors. Technical liaison for related FDA related manufacturing test. Jan 2013 – March 2017 Sierra Nevada Corporation.

Reno, NV

Sr. Systems Engineer, Tele-Medicine

Responsible for commercial telemedicine projects. Charged with all systems engineering efforts associated with development and release of Medical Device solutions serving the Telemedicine Market. Efforts include compliance and regulatory management, Quality Management System design and install, customer training, and pilot launch activities. Developed web driven interfaces, systems and products while adhering to all 21CFR820.30 FDA standards and applicable HIPAA and HITECH Act security guidelines.

Achievements:

• Integrated tactical telemedicine solutions to commonly deployable equipment such as: o Nett Warrior Samsung Android devices, AN/PRC-154A Rifleman Radio, PRC- 117F/G Multiband Manpack Radio, IMAGINET Tactical Radio Network

• Principal Investigator for Office of Naval Research (ONR) Telemedicine Research program.

• Established and maintained HIPAA training program for all telemedicine employees.

• Developed and deployed secure HIPAA compliant cloud based technologies to support telemedicine transactions.

• Supported NIE 15-2 for T2 Transport Telemedicine Project in El Paso TX

• Authored patents for commercial and military Telemedicine. Awards:

• Spot award for authoring HIPAA compliant processes.

• Spot award for participation of team efforts resulting in selling first Commercial Telemed product.

• Spot award for successful negotiations and relationship repair with key vendors. Nov 2010 – Jan 2013 Titus Innovations. Reno, NV

Owner and CEO

Small Consulting Company specializing in project management/recovery and engineering design. Performed all business development and backend business functions while maintaining customer relationships and performing engineering design.

- Test Engineering Consultant to Myriad Systems for Tazer March 2013 – Dec 2013 Management and Business Development: Worked closely with customers at Tazer to develop a manufacturing test solution that met both quality needs and budget. Product Design and Test Development: Utilized USB controller hardware from National Instruments along with LabView 2012 to build logic test sequence and test fixture to test Tazer’s new On-Officer Video Platform

- Project Engineering Consultant to Phoenix Logistics Nov 2012 – March 2013 Product Design and Test Development: Engineer responsible for the design, deployment, support, of a new test technologies designed to help personnel debug MIL-STD-1553 cable issues. Automated system designed to run off of host PC or laptop and provide USB interface to hardware designed for testing. In charge of all hardware and software development. Software developed in LabView 8.5 and LabView2012. Create custom software interface to hardware using .dll calls and .NET components. Worked with equipment vendors to establish LabView libraries for all equipment that did not have vendor libraries established.

- Project Management Consultant to Jabil Circuit Nov 2010 – Oct 2012 Management: Responsible for project performance/management, schedule, budget, regulatory compliance, and test development customer relationship. As a contracted Project Manager responsibilities included regular communication with Jabil’s customers such as EMC, IBM, McAfee, Boston Scientific, and Covidien as well as internal Jabil work cell groups located in St. Petersburg FL, Wuxi China, Shanghai China, and Hungary.

Regulatory Compliance: Responsible for rewriting and deploying new processes for global test development that enforce FDA compliance while maintaining flexibility for product not regulated by FDA.

Test Development: Responsible for conducting all Test Stand 2010 and LabView 8.6, 9.0 related code reviews and related training for product regulated by FDA. Activities include test development, and the establishment of best practices and process model to insure compliance wit all FDA CFR21 regulations.

Accomplishments: Successfully deployed several production test systems to Jabil Wuxi and Jabil Hungary. Successfully launched new test development global quality initiative to further standardize ongoing test development activities while adding support documentation for FDA compliance where needed.

March 2010 – Oct 2012 Neptune Mobile Devices Inc. Phoenix, AZ Owner, President, CEO

Neptune Mobile Devices develops and deploys modular devices that augment existing Military Vehicle maintenance tool sets. Technologies developed and marketed are used to increase vehicle readiness and decrease vehicle lifetime maintenance costs through the use of proprietary vehicle bus monitoring systems coupled with Predictive Maintenance Algorithms. Specific focus on the decode of MIL-STD-1553 bus traffic with limited access to interface control documentation (ICD’s). Sept 2008 – Feb 2010 Neptune Systems Contracting for DRS Huntsville, AL Sr. Systems Engineer, and Software Engineering Consultant (1099 Contract) Management: Managed and lead software development team. Participated in all major government meetings (PDR, CDR, TRR, DD-249 Acceptance). Maintained requirement tracking systems at the individual signal level for over 2500 individually monitored or driven signals. Managed inter- departmental and customer activities through the use of requirements and deadlines. Accomplishments: DD-250 government acceptance and on time/under budget delivery of the SIL. Systems/Software Development:

- Systems Engineer and Software Lead (LabVIEW) for a congressionally funded Systems Integration Laboratory for the M1A1 Abrams Main Battle Tank. The facility is aimed at accelerating the integration and deployment life-cycle of new and advancing technology into the M1A1 family of vehicles.

Sept 2005 – Sept 2008 Inter-Coastal Electronics (ICE) Mesa, AZ Manager - Test Engineering Department/Systems Engineer III Oct 2005 - Sept 2008 Activities: Managed labor and budget required to support production needs and required throughput. Test Department Manager responsible all activities involving production level testing. Designed and developed all test methodologies and specifications for production, systems, and integration level testing.

Accomplishments: Reduced test times 300% in six months by implementing new training and equipment accrued through self-funded efforts due to budget constraints. ISO-9001 certification achieved Sept 2009. Established design for testability policy companywide on all new products. Designed and fielded military collective force on force training products for US Army and US Marine Corps.

Experience integrating technology on the following platforms: OH-58D Kiowa Warrior Light Attack Helicopter, AH-64 Apache Attack Helicopter, CH-47 Chinook Heavy Lift Helicopter, UH-60 Black Hawk Utility Helicopter, AH-1 Cobra Attack Helicopter, M1134 Stryker ATGM Anti Tank Guided Missile Variant of the light armor wheeled vehicle, M2 Bradley IFV Infantry Fighting Vehicle, M1A1 Abrams Main Battle Tank, ITAS TOW HMMWV (Humvee) mounted guided missile launcher.

Feb 2004 – Oct 2005 Medtronic Microelectronics Tempe, AZ Sr. Test Engineer

Activities: Test Engineer for the ADM IPG/ICD Test area. Participate in qualification and release of both hardware and software for test solutions. Assist in supporting manufacturing floor with necessary hardware, software and test system configuration. Act as a liaison between development facilities and high volume manufacturing facilities worldwide. Responsible for generating and defending test documentation to be reviewed in FDA, European Health Organizations, and internal audits. Support on site installation of production test equipment in Romania, Switzerland, and Puerto Rico.

June 2001 – Feb 2004 Honeywell CAS Glendale, AZ

Test Engineer June 2003 - Feb 2004

Supported and developed test hardware and software for the testing of DU-1080 and DU-1310 avionics flat panel displays.

- Experience with Boeing 777 flat panel displays.

- Design of End Item, Burn In, and HASS test software using National Instruments Labview 5.0 and Test Stand, Microsoft Visual Basic 6.0, and Honeywell proprietary JAX and KIA applications.

- Test and Debug of Primus EPIC MAU Avionics components Verification Engineer June 2001 - June 2003

Verification and Validation Engineer assisted in the hardware verification and validation process. Supports FAA certification of hardware system. Experience with the Honeywell Primus EPIC MAU for use in commercial aircraft. Performed verification activities on Dassault, Gulstream, Embrear, and Augusta aircraft MAU components for use in the Primus EPIC avionics systems. Patents:

US PATENT 10/531,328: ADAPTABLE ULTA-NARROWBAND SOFTWARE DEFINED RADIO DEVICE, SYSTEM, AND METHOD

Awarded January 7, 2020

US PATENT 201******** TELEMEDICINE SYSTEM

Awarded January 4, 2018

US PATENT US6845851B1 Braking control system for a vehicle being towed by another vehicle Awarded January 1, 2005

Education:

Student

2008 – Dec 2009 Thunderbird School of Global Business Glendale, AZ MBA in Global Business Management 3.5 Cumulative GPA Student

1998 - 2002 Embry Riddle Aeronautical University Prescott, AZ Bachelors of Science in Electrical Engineering 3.1 Cumulative GPA General Management

Business Strategy, Market Analysis, Business Intelligence, Game Changing Technology Analysis, Employee Compensation, Investment Strategy, Alignment of Corporate Goals, R&D Management, Tools: SWOT Analysis, Porter Five Forces, Budget Analysis, Cash Flow Statement, Balance Sheet Business Development

Writing Proposals both DoD and Commercial, Generating Presentations, Customer Follow Up, Customer Service, Sales, Cold Calling, RFP, FRQ, Estimating, Contract Development, Contract Negotiation Tools: Trade Shows, SBA, fbo.gov, Direct Marketing, Linked In, MS Power Point, MS Word, Mac Keynote, Mac Pages

Project Management

Regular Stake Holder Reviews, SDL Software Development Lifecycle, Product Development Lifecycle, Budget Analysis, Project Analysis, Burn Rate, Global Team Management, Global Project Management, Contract Manufacturing, DCMA Acceptance, DD-249, DD-250, Tools: MS Excel, Mac Numbers, MS Project, SQL, Gant Chart, Association Chart, Compliance

CFR21820.30, DO-178B, DO-160, DO-254, ISO-9001, ISO 13495, IEC 62304, ISO 14791, FDA design compliance

Tools: Alfresco, SVN, CRC, Gerber, Requirements Traceability Matrix, DOORS, Documentation:

SDD (Systems Description Document), SRD (Systems Requirements Document), HDD (Hardware Description Document), HRD (Hardware Requirements Document), SWDD( Software Description Document), SWHD (Software Requirements Document), TDD (Test Description Document), TRD (Test Requirements Document), VDD (Verification Description Document), VHD (Verification Requirements Document), Windchill, Alfresco, PVCS, Helix, SeaPine Test Track, CatsWeb. Systems Development

Mentor and Trainer, Requirements Generation, Requirements Tracking, Systems Architecture, System Design, Cross Functional Team Development, Control Systems Design, Closed Loop Control Design, Interface Control Document Design, IRAD (Internal R&D) Hardware Development

Hardware Design, Digital Design, Analog Design, Mixed Signal Design, RF Design, Power Management, Schematics, PCB Layout, Hardware Verification, 904nm Laser Design, 830nm Laser Design, RF Design Tools: Orcad Layout, PSPICE, Mentor Graphics, PCB123, PCB Express, MIL-STD-1275 /704 Software Development

Software Design, Software Architecture, GUI creation, Test Software Creation, Product Software Creation, Embedded Software, Application Software, Database Management Tools: Version Control, VSS, SVN Tortoise, LabView, C, C++, C#, SQL, Visual Basic Test Development

HALT, HASS, ESS Testing, NPI (New Product Introduction Testing), Test Design, Qualification Testing, MIL-STD-810, MIL-STD-461, Medical Product Testing, Aerospace Testing, Defense Product Qualification Testing.

V&V Verification and Validation

Traceability Matrix, Articles of Evidence, Hardware Verification, Software Verification, FPGA verification,

Communication Protocols

MIL-STD-1553, USB, RS-232, RS-422, GPIB, IEE-488, Ethernet, TCP-IP, 802.11, 802.14, VHF, UHF, Single Side Band Suppressed Carrier, Half Duplex, Full Duplex, Master Slave Bus, Multi Master Slave Bus, Point to Point Communication, Interface Control Documentation (ICD)

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