Louis Evans

acvaw6@r.postjobfree.com 361-***-****

SUMMARY:

Engineer experienced in supporting/driving R&D, technical transfer of new products/processes from R&D to manufacturing, and the development of manufacturing processes, technologies, processes, and product improvement projects for Medical Device products and production projects in compliance with 21CFR820 & ISO13485.

Extensive experience in process and design controls, development, testing, and troubleshooting; overseeing implementation of new processes; utilizing LEAN, Six Sigma principles and continuous improvements for transfer of products and processes and manufacturing and production process implementation

Ability to oversee production projects, creating and implementing new strategies to improve process efficiency, and support start-up activities; writing protocols and reports, as well as controlled documentation; managing/ reading engineering drawings, specifications and requirements.

Direct experience creating and maintaining automation processes, for opto-mechanical, electro-mechanical, chemical, electrical and mechanical systems/ devices/instruments; performing corrective actions and preventive actions (CAPA), supporting product development processes (PDP) and production; and collaborating with cross functional teams on design deliverables, ensuring deliverables and designs adhere to requirements and regulations

Detailed knowledge of and exposure to Statistical Process Control (SPC), Effects Analysis (FMEA), Criticality analysis (CA), Maintainability Information (MI), to provide structured, qualitative, and analytical framework for manufacturing and production projects oversee and manage the migration of legacy documents into Client's document management system Display Testing

In-depth experience performing advanced troubleshooting of electro-mechanical test equipment, preventative maintenance, and wiring and soldering; working with pressure, temp, flow and level devices and control valves; as well as, bedside monitors, Ekg, spo2, blood pressure cups, telemetric system, electrical & opto-mechanical systems involved in new Products Development/ Introductions (NPD/I) for Medical Devices

Responsible for driving NPD (new product development) processes, continuous improvements, efforts to transfer product from R&D into production; identifying Non-Conforming parts (NC), relate to Supplier involved in new work Development Products; conduct engineering changes on product line and process validations under GMP, 21CFR Part 820/ ISO 13485.

Experienced in diagnosing root cause (RC) issues and perform failure mode and effects analysis (FMEA) to component level, report write-up and resolve problems on sophisticated electronic and mechanical instrumentation in commercial scientific laboratory environments

Experienced in New Product Development/ Introductions (NPD/ NPI); interfacing with design, quality, R&D, mfg. engineers, and business units to provide feedback on proposed designs and influence organization to develop strong Design For Manufacturability (DFM) products (including opto- mechanical/ electro-mechanical products and medical devices)

Experience with both analog and digital circuit design, failure analysis to component level, and repair low and high voltage electrical equipment; performing report write-up; identifying Non-Conforming (NC) parts for medical devices and products; working with PID Engineer Terminals; conducting Process and Quality System Audits; and documenting procedures, maintenance and calibration in accordance with best engineering practice

Hands-on experience conducting R&D product V&V tests based on test protocol/ criteria; performing FMEA’s and Root Cause Analysis (RCA); generating reports/ performance metrics; executing Process and Quality System Audits, Process validation under GMP, 21CFR Part 820, ISO 13485; driving CAPA, quality, and continuous improvements, applying LEAN and Six Sigma methodology

Thorough experience performing reworks for analog and digital circuit boards, surface mount and through hole printed circuit boards, and debugging system level electro-mechanical assemblies and performing hand soldering according to FDA, ISO, CFR, and MIL- SPEC

Operate test machinery and equipment in order to test prototypes, perform routine maintenance. Build testing tools and fixtures; perform Analysis of trade-offs between choices of circuits and components to specify the design of embedded systems; create test protocols, manual and automated, to validate design parameters and find design errors’ identifying nonconforming

EDUCATION:

MS Engineering (In Progress), San Diego State University

Bachelor of Science Electronic Applied Science in Electrical Engineering, ITT Technical Institute, San Diego, CA. Dean’s List

Associate of Science Chemistry, Imperial Valley College, Imperial Valley, CA

Member Society of Electronic Engineers

PROFESIONAL EXPERIENCE:

Irvine Pharmaceuticals

8/2015- 10/28/2015

Project Manager .Electrical Engineer (Contract)

Support the development of manufacturing processes, technical transfer of new products, technologies, processes, and product improvement projects oversee and manage the migration of legacy documents into Client's document management system Display Testing

Responsible for creation and release of manufacturing and test documentation.

Responsible for writing protocols and reports, as well as controlled documentation; manage/ read engineering drawings, specifications and requirements. ultrafiltration skids, process tanks, and automated CIP/SIP systems; Lab view

Perform complex machinery problem solving of semiconductor equipment in production environment for Metrology area, and participate on problem solving teams.

Able to develop his/her own resources to solve problems, and provides imaginative solutions to a broad range of difficult problems producing significant results.

Analyze recurring equipment failures and suggest innovative technical solutions, or new work methods.

Lead and direct the activities to develop/improve existing semiconductor equipment maintenance procedures and systems. Coordinate technical teams to ensure sound experimental design, effective data analysis, risk analysis, design verification and validation and subsequent closure to technical investigations.

Collect equipment-specific performance data working with Process Engineering to develop and implement solutions to equipment-specific failures based on collected Pareto data, and tool deficiencies.

Provide technical equipment-specific training to lower level technicians.

Interface and direct vendor support to resolve equipment related failures.

Ability to perform diagnostic troubleshooting and repair on malfunctioning equipment to component level (diagnostic to component level), as needed.

Ability to assist in resolving process issues and participate in yield investigations

Proper judgment is required in resolving problems and carrying out assignment and making recommendations

Participate and lead/direct ERT/Safety events, during the absence of supervision.

I have Experience with AutoCAD, National Instruments, Visual Basic, Lab View, Lab Windows, Daktronics System 10, and ability to integrate data from different pieces of equipment with different operating systems into a common data base. And working knowledge of PLC programming is also necessary solid mechanical aptitude.

GE Oil & Gas, Houston, TX

4/2015- 7/2015

Project Manager/Electrical Engineer

Process control engineers design, test, troubleshoot, and oversee implementation of new processes.

Support and drive LEAN, Six Sigma principles and continuous improvements for transfer of products and processes and manufacturing and production process implementation, projects oversee and manage the migration of legacy documents into Client's document management system I have Experience with AutoCAD, National Instruments, Visual Basic, Lab View, Lab Windows, Daktronics System 10, and ability to integrate data from different pieces of equipment with different operating systems into a common data base. And working knowledge of PLC programming is also necessary solid mechanical aptitude.

Design and install retrofits to existing systems and troubleshoot hardware, software, and instrument problems.

Oversee production projects, creating and implementing new strategies to improve process efficiency, and support start-up activities.

Responsible for creating and maintaining automation processes, for opto-mechanical, electro-mechanical, chemical, electrical and mechanical systems/ devices/instruments.

Manage and support Statistical Process Control (SPC), Risk Management, Process Failure Modes and Effects Analysis (PFMEA), Criticality analysis (CA), Maintainability Information (MI), to provide structured, qualitative, and analytical framework for manufacturing and production

Pickettsystems, Corpus Christi, TX

08/2014-1/5/2015

Project Engineer/ Manager/Electrical Engineer

Oversee all maintenance, facilities, process, and engineering needs pertaining to electrical/ opto-electrical/ opto-mechanical systems. ultrafiltration skids, process tanks, and automated CIP/SIP systems;

Assists with performing wiring, materials update drawings, maintenance planning, developing standard operations and maintenance procedures, and prepares project work bid sheets and contracts for construction and facilities acquisition.

Perform corrective actions and preventive actions (CAPA), support product development processes (PDP) and production collaborating with cross functional teams on design deliverables, ensuring deliverables and designs adhere to requirements and regulations, I have Experience with AutoCAD, National Instruments, Visual Basic, Lab View, Lab Windows, Daktronics System 10, and ability to integrate data from different pieces of equipment with different operating systems into a common data base. And working knowledge of PLC programming is also necessary solid mechanical aptitude. Acts as SME for all Electrical needs in Manufacturing / Maintenance and Large Capital Equipment Projects working with Supplier Quality

Conducts preliminary surveys and prepares schematic, preliminary, and work drawings for the construction and maintenance of new or remodeled structures and Pipelines and Skids.

Completes correspondence involving technical problems concerning electrical engineering

FMC Technologies, Corpus Christi, TX

08/2013-08/2014

Field Service Engineer/Project Manager. (Travel 80% international /Saudi Arabia)

Perform advanced troubleshooting of electro-mechanical test equipment issues and preventative maintenance. Experience working with pressure, temp, flow and level devices as well as control valves.

Extensive wiring and Soldering, involved in new work Development Products

Interface with design engineers to provide feedback on proposed designs and influence organization to develop a strong design for manufacturability culture.

Experience with both analog and digital circuit design, failure analysis to component level, report write-up Identifying nonconforming parts Lab view

Documentation of procedures, maintenance and calibration in accordance with best engineering practice work with PID Engineer Terminal. Conduct Process and Quality System Audits

Install, test, main, troubleshoot and repair low and high voltage electrical equipment Read, understand and effectively utilize technical information from electrical schematics, vendor information procedures and codes.

Ensure work is done in compliance with electrical (NEC and NFPA) codes

Strictly adhere to and enforce safety procedures as required by power plant and OSHA Calibrate and use test equipment associated with the power plants electrical and safety systems. I have Experience with AutoCAD, National Instruments, Visual Basic, Lab View, Lab Windows, Daktronics System 10, and ability to integrate data from different pieces of equipment with different operating systems into a common data base. And working knowledge of PLC programming is also necessary solid mechanical aptitude. Responsibilities include completion of daily work schedule, testing, calibrating and commissioning (IQ, OQ, PQ) of instrumentation within the Corpus Christi maintaining data sheets and technical documentation. Perform Instrument turnaround maintenance activities (ID potential scope items, enter t/a work orders, lead work crews for scope as assigned, and perform instrument scope work Software, Fuel cells plot curves Excel, sheet Pivot, proficient in Office, particularly Word.

Carefusion, Yorba Linda, CA

2/2012 6/2013

Sr. Electrical Engineer/Electrical Engineer

Responsible for supporting/performing transfer of new products and technologies, process/product improvement projects, creation and release of manufacturing and test documentation

Conduct R&D product V&V tests based on test protocol or criteria; report results to appropriate engineer Conduct Process and Quality System Audits, RF ablation

Perform Process validation under GMP, 21CFR Part 820, ISO 13485. Drive and implement CAPA, FMEA, quality, and continuous improvements.

Tests and repairs equipment debug and failure analysis (FMEA) to component level. Conducts engineering changes (ECO) on product lines. Display Testing

Responsible for generating metrics, report write-ups, and process/controlled documentation; read blueprints/schematics; apply LEAN and Six Sigma methodology

Perform rework for analog and digital circuit boards, debug system level electro-mechanical assemblies and perform hand soldering; perform Root Cause Analysis (RCA) Lab view

According to FDA, ISO, CFR, and MIL- SPEC perform reworks on surface mount and through hole printed circuit boards

Operate test machinery and equipment in order to test prototypes, perform routine maintenance. Build testing tools and fixtures

Solicit design input from engineers and coordinate efforts with Suppliers, machine shop, etc. Input resolution to resolve problems with materials.

Prioritize test tasks on equipment and manpower allocation per instruction from supervising manager.

Lead lower level R&D Test Technicians, intern train on proper testing, safety procedures Analysis of trade-offs between choices of circuits and components to specify the design of embedded systems.

Creates test protocols, manual and automated, to prove design parameters and find design errors’ identifying nonconforming parts and relate to Supplier.

Communicates professionally with, from time to time, articles, patents, white-papers or other technical exposition.

Schedule assurance by providing input in the planning phase and by consistent, detailed progress reporting during execution.

Performs engineering support for ongoing operations through evaluation of second-sources and vendors. Work with PEP Input/Output power interface, for shelters of all classification in the DOD portfolio. +24/28 VDC to 200 Amps and 3-Phase AC to 60 Amp per phase input/output distribution capability. The PEP device meet Army required

LaboMed, Corp. Los Angeles, CA

9/2009 – 12/2011

Project Manager./Electrical Engineer

Diagnose root cause (RC) issues and perform failure mode and effects analysis (FMEA) to component level, report write-up and resolve problems on sophisticated electronic and mechanical instrumentation in a commercial scientific laboratory environment.Display Testing

Responsible for driving NPD (new product development) processes, continuous improvements, efforts to transfer product from R&D into production.

Work independently and effectively with clients to troubleshoot, install, maintain and service scientific instruments such as HPLC, GC, UV and LC/MS

Responsible for identifying nonconforming parts and relate to Supplier involved in new work Development Products

Oversees and provides appropriate and timely response to service requests. (Microsoft Office, Microsoft Windows, excellent programming and troubleshooting skills. Agilent, sotax, (vendors) H.P., Varian.

Monitors and reports trends in team support for calls from users using Labomed, products and evaluates and corrects situations accordingly.

Oversees the creation, distribution and integrity of Technical Documentation for Labomed, products Perform Process validation under GMP, 21CFR Part 820; ISO 13485

Ensure all medical devices and products are appropriately supported and monitor/maintain processes, applications for Device and Technologies

Ensures appropriate technical knowledge base and support documentation are maintained for support of all Labomed, products Drive inspection and NCR's and report back to supplier

Designs and provides training in the use of Device and software applications.

Establishes work priorities and evaluates cost and time requirements.

Reviews completed projects to ensure that goals are met.

Promotes a safe environment in the use of technology and stays informed of applicable safety regulations.

Has knowledge of set –ups, Standards, calibration. Run tests spreadsheet, STD deviation, dilution

Makes recommendations for improvements in information management and advises as to compatible purchases. Analysis of trade-offs between choices of circuits and components to specify the design of embedded systems.

Creates test protocols, manual and automated, to prove design parameters and find design errors.

Communicates professionally with, from time to time, articles, patents, white-papers or other technical exposition.

Provides schedule assurance by providing input in the planning phase and by consistent, detailed progress reporting during execution.

Kimco Technology Group

8/2009- 8/2011

Quality Engineer/Electrical Engineer

Completes quality product repairs promptly for: bedside monitors, Ekg, spo2, blood pressure cups, telemetric system, repair of electrical & opto-mechanical systems. work involved in new Products Development/ Introductions (NPD/I) for Medical Devices

Tests and repairs equipment debug and rework analog and digital circuit boards, debug system level electro-mechanical assemblies hand solder; mil spec experience rework surface mount and through hole printed circuit boards read blueprints/schematics, RF ablation Lab view Display Testing

Conducts engineering changes on product line Process validation experience under GMP, 21CFR Part 820 Cappa.

Identifying nonconforming parts and relate to Supplier.

Documents all problems failure analysis to component level, report write-up and repair requirements

Other duties as assigned travel client site do repairs install.

Responsible for assisting with a warranty repair of either installed components or unshipped in-house components of medical devices.

Sr. Systems Engineer/Electrical Engineer, Secure Communication Systems (Kimco Contract)

Supported engineering activities such as design, solid works test, checkout, modification, fabrication and assembly of prototype electro-mechanical systems, experimental design circuitry or specialized test equipment.

This included analog, digital and/or video circuits, and logic systems. Worked from schematics, diagrams, and written and verbal descriptions, layouts or defined plans to perform testing, checkout and trouble-shooting functions.

Performed operational test and fault isolation on systems and equipment.

Assisted in determining methods or actions to remedy malfunctions. Review and Process change requests

Assisted in the design, construction, test and checkout of test equipment.

Used manufacturing, test, development or diagnostic equipment, including, but not limited to, test programs oscilloscopes, signal generators and specialized test apparatus.

Set-up test benches in systems lab, including cable definition and build as well as system configuration and trouble-shooting. Lab view,Display Testing

Conducted systems investigations on a wide range of subject from RF performance, to Ethernet network investigations and report results.

Conducted system level testing according to systems Test Modules and report results.

Maintained lab equipment as required, including logging in new assets, tracking existing assets, coordinating calibration of test equipment, etc.

Clear Edge Power

8/2008 - 8/2009

Project Manager./Electrical Engineer

Perform advanced troubleshooting of electro-mechanical test equipment issues. And preventative maintenance. Install, test, main, troubleshoot and repair low and high voltage electrical equipment Read, understand and effectively utilize technical information from electrical schematics, vendor information procedures and codes.

Interface with design engineers to provide feedback on proposed designs and influence organization to develop a strong design for manufacturability culture. Lab view

Experience with both analog and digital circuit design, failure analysis to component level, report write-up. Working with Transtector's DC Edge Series of high amperage DC power distribution unit’s scalable and reconfigurable edge networks. Transtector’s DC PDUs compact, robust and convey up to 7500 watts per individual output. Models are vailable with remote and visual status monitoring, universal DC power distribution of 24Vdc and -48Vdc, breaker and fuses and multiple rack mounting. Drive inspection and NCR's and report back to suppliers

Documentation of procedures, maintenance and calibration in accordance with best engineering practice work with PID Engineer Terminal. Software, Fuel cells plot curves Excel, sheet Pivot, proficient in Office, particularly Word. Review and Process change requests Display Testing

Ensure work is done in compliance with electrical (NEC and NFPA) codes strictly adhere to and enforce safety procedures as required by power plant and OSHA Calibrate and use test equipment associated with the power plants electrical and safety systems.

Guidant (owned by Boston Scientific)

1/2007 – 7/2008

Component Qualification Engineer (Project Management Level)/ Electrical Engineer (Medical Devices)

Develop and review electrical testing and troubleshooting procedures for hybrid and implantable defibrillator electronics. work Development involved in new Products

Perform advanced troubleshooting of electrical test equipment issues. FMEA,,VV, RF ablation

Interface with design engineers to provide feedback on proposed designs and influence organization to develop a strong design for manufacturability culture. Lab view

Experience with both analog and digital circuit design. Process validation experience under GMP, 21CFR Part 820 Cappa.,brown belt Review and Process change requests

Documentation of procedures, failure analysis to component level, report write-up maintenance and calibration in accordance with best engineering practice, quality system and regulatory requirements .multitasking Project Management. Statistical skills, run mini -Tab analysis. Conduct Process and Quality System Audits

Expertise in electrical instruments, components, products, and systems for commercial, industrial, or scientific use. Inspect and evaluate damages to different types of equipment/systems. Analysis of trade-offs between choices of circuits and components to specify the design of embedded systems.

Creates test protocols, manual and automated, to prove design parameters and find design errors. Identifying nonconforming parts

Communicates professionally with, from time to time, articles, patents, white-papers or other technical exposition.

Provides schedule assurance by providing input in the planning phase and by consistent, detailed progress reporting during execution. Display Testing

Performs engineering support for ongoing operations through evaluation of second-sources, interfacing with Supplier. Drive inspection and NCR's and report back to suppliers

SKILLS/ EXPERIENCE:

10 years Senior Technician, 5 yrs. Electrical Engineer, 5 yrs PLC Allen Bradley. 10 years of experience in electro-mechanical and electronic circuits and preventative maintenance for manufacturing.

Experienced in both digital and analog circuits. Experienced in programming and instrumentation device (P&IDs) control systems. Experienced in Supplier Quality

Ability to work on x-ray, c-arm equipment, ultrasonic assembles through hole, SMT, wiring, RF digital and analog circuitry.

Solid works Mentor Graphics Questa Sim 6.6a, ISE Project Navigator, Process validation experience under GMP, 21CFR Part 820 CAPA. FMEA, work Development involved in new Products

SMT, OSHA certified, crimping, soldering, fine-pitch, rework, set-up programming instrumentation, Troubleshoot to component level, spectro analysis, PLC and PCB systems. Display Testing

Strong problem solving skills within: hydraulics, motors, pneumatics pumps UV GC, AA, digital multi-meter and function generator. Java, C++, Minitab, lab-view, visual basic, block diagram, mechanical to mill spec, oscilloscope millimeter. PCB Assembly and Cleaning experience

Computer Skills: (Microsoft Office, Microsoft Windows, excellent programming and troubleshooting skills. Agilent, sotax,(vendors) H.P., RF ablation

Contact this candidate