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Sr. Project Engineer Resume

Hayward, CA

SUMMARY

  • Engineering professional with over 10 years of experience in Project Management, Electrical Engineering, and manufacturing.
  • Project Management experience.
  • Process validation experience under GMP, 21CFR Part 820 CAPPA, FEMA, Title 24 and Work Development involved in new Products
  • Knowledge of Design Controls and Process optimization experience
  • Excellent problem solving and troubleshooting skills.
  • 10 years of experience in electro - mechanical and electronic circuits and preventative maintenance for manufacturing. Experienced in both digital and analog circuits.
  • SMT, OSHA certified, crimping, soldering, fine-pitch, rework, set-up programming instrumentation, Troubleshoot to component level, spectra analysis, PLC and PCB systems.
  • Experienced in programming and instrumentation device (P&IDs) control systems. STD­001 and IPC­A­610

TECHNICAL SKILLS:

  • SolidWorks, schematic capture/PCB generation experience in CAD software
  • test equipment architectures (VXI, PXI, Rack and Stack, etc)
  • Knowledge of communication protocols (Modbus, Ethernet, CAN, Profibus, etc)
  • Electronic circuit knowledge: digital, analog, power and high voltage
  • Experience with electrical and pneumatic systems
  • ISO9000/AS9100 and MIL Standard
  • Java, C++, Minitab, LabVI
  • EW, Visual Basic, block diagram, mechanical to mill spec, oscilloscope millimeter. Orcad, AutoCAD, Pro-E. and process optimization experience
  • Computer Skills: (Microsoft Office: Word, Excel, and PowerPoint), Agilent, sotax, (vendors) PMP

PROFESSIONAL EXPERIENCE

Confidential, Hayward, ca

Sr. Project Engineer

Duties and Responsibilities:

  • Develop URS and Project Plan in collaboration with Impax personal to finalize project scopes and related cost, schedules, and qualification of equipment.
  • Manage the implementation and execution of projects activities related to contractors and all functional groups (manufacturing, technical services, quality, and validation, etc.)to successfully complete all projects.
  • Follow internal SOPs throughout the project life-cycle covering planning, design/engineering, procurement, execution, and qualification.
  • Assist in the selection of equipment and management of vendor relationships, including fees negotiations In accordance with cost- benefit analysis and Capital equipment over 3 million dollars
  • Obtains and evaluates the input of team, company personnel, and contractors to identify and resolve potential project delays, scope changes, and/or scope discrepancies
  • Ensure that project team members monitor project progress and performance when applicable
  • Manufacturing procedure development, manufacturing test procedures, engineering changes (ECN), and process optimization experience
  • Follow and execute corporate procedures including build to quarantine, rework jobs, expedite material from stores to the floor, first time buy, supplier approvals, protocols, test reports, and inspection method development.
  • Thorough knowledge and experience with engineering drawings, specifications and requirements.
  • Working knowledge and experience with ISO 13485 and transfer of Medical Devices from R&D to Manufacturing

Confidential, Irvine, CA

Project Engineer/Electrical Engineer (Contract)

Responsibilities:

  • 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.
  • Lead and direct the activities to develop/improve existing semiconductor equipment maintenance procedures and systems. GMP, 21CFR Part 820 CAPPA, FEMA . Title 24
  • 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; LabVIEW
  • Perform complex machinery problem solving of semiconductor equipment in production environment for Metrology area, and participate on problem solving teams.
  • Analyze recurring equipment failures and suggest innovative technical solutions, or new work methods.
  • 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 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
  • Participate and lead/direct ERT/Safety events, during the absence of supervision.
  • Ensure all required parts are on order and follow up as required to minimize equipment.
  • Requires minimal management supervision to perform daily routines.
  • Manufacturing procedure development, manufacturing test procedures, engineering changes (ECN), and process optimization experience
  • Follow and execute corporate procedures including build to quarantine, rework jobs, expedite material from stores to the floor, first time buy, supplier approvals, protocols, test reports, and inspection method development.
  • Thorough knowledge and experience with engineering drawings, specifications and requirements.
  • Working knowledge and experience with ISO 13485 and transfer of Medical Devices from R&D to Manufacturing

Confidential, Houston, TX

Project Engineer /Electrical Engineer (Contract)

Responsibilities:

  • Design, test, troubleshoot, and oversee implementation of new Stage-Gate 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 LabVIEW Display Testing
  • 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 start­up activities.
  • Responsible for creating and maintaining automation processes, for opto-mechanical, electromechanical, 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

Confidential, Corpus Christi, TX

Project Manager

Responsibilities:

  • Oversee all maintenance, facilities and engineering needs
  • 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.
  • Acts as SME for all Electrical needs in Manufacturing / Maintenance and Large Capital Equipment Projects
  • Conduct walk down’s, preliminary surveys, and schematic, for the construction and maintenance of new or remodeled structures, Pipelines and Skids.
  • Completes correspondence involving technical problems concerning electrical engineering
  • Power Distribution Design/ Power Design- ANALOG Signal
  • Prime Power analysis and design
  • UPS, PS source selection
  • Reactance and Power Factor analysis
  • Assuring compliance to EPA governing specifications

Confidential, Corpus Christi, TX

Field Service Engineer

Responsibilities:

  • 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.
  • 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.
  • Experience working with pressure, temp, flow and level devices as well as control valves.
  • Responsibilities include completion of daily work schedule, testing, calibrating and commissioning 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
  • 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
  • Documentation of procedures, maintenance and calibration in accordance with best engineering practice work with PID Engineer Terminal.
  • Power Distribution Design/ Power Design- ANALOG Signal Prior RF power amplifier hardware design for frequencies above 2 GHz to 10 GHz
  • Assist in the selection of equipment and management of vendor relationships, including fees negotiations In accordance with cost- benefit analysis and Capital equipment over 3 million dollars
  • RF CAE tool experience with VSS and\or Ansoft HFSS (analog and digital tool experience a plus)
  • Experience in requirements generation and validation, allocation and traceability
  • Experience with documentation and spreadsheet tools e.g. Microsoft Excel, PowerPoint, Project, Word, etc.
  • Ability to understand and be capable of interpreting, investigating, designing, and testing to the current version of DO-254
  • Branch circuit wiring for cabling design
  • Prime Power analysis and design
  • UPS, PS source selection
  • Reactance and Power Factor analysis
  • Software, Fuel cells plot curves Excel, sheet Pivot, proficient in Office, particularly Word.

Confidential, Yorba Linda, CA

Sr. Electrical Engineer

Responsibilities:

  • Tests and repairs equipment debug and failure analysis to component level, report write-up, 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
  • Conducts engineering changes on product line. Process validation experience under GMP, 21CFR Part 820 CAPPA, FEMA 13845
  • Conduct R&D product V&V tests based on test protocol or criteria; report results to appropriate engineer
  • 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 vendors, machine shop, etc.
  • Input resolution to resolve problems with materials.
  • Work on implementing corrective action, materials, conditions or problems
  • 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.
  • 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.

Confidential ., Los Angeles, CA

Engineer (Manager)

Responsibilities:

  • Diagnose failure analysis to component level, report write-up and resolve problems on sophisticated electronic and mechanical instrumentation in a commercial scientific laboratory environment.
  • Work independently and effectively with clients to troubleshoot, install, maintain and service scientific instruments such as HPLC, GC, UV and LC/MS 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. involved in new work Development Products
  • 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 Process validation experience under GMP, 21CFR Part 820 CAPPA, FEMA 13845.
  • Ensures all products are appropriately supported.
  • Ensures appropriate technical knowledge base and support documentation are maintained for support of all Labomed Products.
  • Maintains a strong background in the application of software and Device Technology.
  • 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.

Confidential

Field Service Engineer

Responsibilities:

  • Completes quality product repairs promptly for: bedside monitors, Ekg, spo2, blood pressure cups, telemetric system, repair of electrical & opto-mechanical systems. work Development involved in new Products
  • 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
  • Conducts engineering changes on product line Process validation experience under GMP, 21CFR Part 820 CAPPA.
  • Documents all problems failure analysis to component level, report write-up and repair requirements
  • Other duties as assigned: travelling to client sites, perform repairs and installations.
  • Responsible for assisting with a warranty repair of either installed components or unshipped in-house components of a medical device.
  • Supported engineering activities such as design, SolidWorks 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.
  • 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.
  • 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.

Confidential

Sr. Field Service Engineer/Supervisor

Responsibilities:

  • Perform advanced troubleshooting of electro-mechanical test equipment issues and preventative maintenance.
  • Install, test, maintain, 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.
  • 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. 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 available with remote and visual status monitoring, universal DC power distribution of ±24Vdc and -48Vdc, breaker and fuses and multiple rack mounting.
  • 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.

Confidential

Component Qualification Engineer (Project Management Level)

Responsibilities:

  • 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
  • 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. Process validation experience under GMP, 21CFR Part 820 CAPPA, Title 24,brown belt
  • 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.
  • Extensive multitasking, Project Management, Statistical skills, run mini -Tab analysis.
  • 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.
  • 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.
  • Performs engineering support for ongoing operations through evaluation of second-sources, interfacing with vendors.

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