Senior Engineer, Validation Resume Samples

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RP
R Pouros
Raheem
Pouros
7749 Grant Mountain
San Francisco
CA
+1 (555) 513 2554
7749 Grant Mountain
San Francisco
CA
Phone
p +1 (555) 513 2554
Experience Experience
Boston, MA
Senior Hardware Validation Engineer
Boston, MA
Davis-Tillman
Boston, MA
Senior Hardware Validation Engineer
  • Develop automation frameworks and test tools
  • Work with design teams to develop validation plans
  • Develop firmware/scripts/applications to test the hardware
  • Develop test software/application
  • Provide supports to internal and external customers
  • Develop scripts for test automation and post processing
  • Develop RTL test designs and firmware to validate transceivers
New York, NY
Senior Hardware Engineer, Validation
New York, NY
Turcotte-O'Kon
New York, NY
Senior Hardware Engineer, Validation
  • Super Cap subsystems development
  • Python & Bash scripting
  • Power Validation (jitter, phase noise, etc.)
  • Strong background in power design, component selection, margining, layout and simulation
  • Bugzilla, GIT and Linux
  • Hot swap power design
  • Power: linear and switched regulators, thermal design
present
Chicago, IL
Senior Computer System Validation Engineer
Chicago, IL
Herzog and Sons
present
Chicago, IL
Senior Computer System Validation Engineer
present
  • Work closely with IT, Business, Regulatory Affairs, and Quality to develop, coordinate and execute Validation documents and strategies
  • Manage and execute decommissioning activities for retired or end-of-life equipment
  • Participate in the development, implementation, execution and adherence to validation procedures and methods related to computer systems validation (CSV)
  • Ensure that the Validation / Qualification and quality systems are working in accordance with any changing and current regulations
  • Recommend acceptance of the computer system, as determined from the CSV tasks performed on the system
  • Play an integral role in Practical Process Improvement (PPI) program
  • Review and approve the relevant documents on validation processes
Education Education
Bachelor’s Degree in Electrical Engineering
Bachelor’s Degree in Electrical Engineering
University of Tennessee
Bachelor’s Degree in Electrical Engineering
Skills Skills
  • Basic knowledge of embedded processors such as ARM Cortex-M3, and familiarity with AMBA protocols APB, AHB, AXI, ACE
  • Knowledge in scripting languages such as TCL and PERL is desirable
  • Experience in system level designs using mixed signal components, NVM (non-volatile memory) highly desirable
  • Possess an in-depth understanding of hardware architectures, system level IC design implementation, knowledge of how to create end use scenarios
  • Knowledge of board level design and debug
  • Excellent verbal and written communication skills in English
  • IEEE 802.3 (Ethernet with MII/RMII/GMII/RGMII/SGMII/XAUI)
  • Experience using Simulation (ModelSim) and Synthesis (Synplicity) tools
  • Optimizing code for FPGA architectures
  • Design with RTL coding in Verilog and VHDL and Verification of RTL
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15 Senior Engineer, Validation resume templates

1

Senior Acoustic Validation Engineer Resume Examples & Samples

  • The ideal candidate should have a strong background in audio/acoustic product development and/or system level validation, together with a good experience of test development and automation
  • 5+ years experience from working within acoustics design or validation of consumer electronic devices
  • In depth usage of acoustic/audio analysis, measurement methods and equipment e.g. ACQUA, SoundCheck, Audio Precision, etc
  • Solid data -analysis, -manipulation, -summary and -presentation skills
  • Knowledge of operators and audio regulatory requirements preferably within telecommunication (3GPP, TIA, VoIP etc…)
  • Familiar with POLQA, PESQ, PEAQ or other quantitative MOS systems
  • Experience with Background Noise recordings and playback systems
  • Scripting experience (e.g. MATLAB, Python)
2

Senior Hardware Engineer, Validation Resume Examples & Samples

  • Locating and specification of components
  • Hot swap power design
  • Power: linear and switched regulators, thermal design
  • Memory: DDR, NAND
  • Signal integrity
  • Basic analog circuitry
  • Schematic capture (Concept preferred)
  • Layout tool (plus Allegro preferred)
  • Spice simulators
  • Field solvers
3

Senior Validation Engineer Biologics Equipment Resume Examples & Samples

  • Consult as a member of a Team of Qualification/Validation Subject Matter Experts on matters concerning facility, utility and equipment (FUE) validation, automated process control (APC) validation, sanitary practices including clean-in-place (CIP) and steam-in-place (SIP), cleaning validation, autoclaves and environmental chambers
  • Design validation test protocols, perform/coordinate validation testing in concert with all stakeholders, and analyze/assemble test results to create a finished validation test protocol as required
  • Perform validation tests, prepare test protocols, and complete documentation necessary to support production activities
  • Review and approve documentation as assigned
  • Review new equipment specifications
  • Manage continuous improvement projects and drive to completion
  • Mentor and guide junior engineers and engineering technicians in the development and execution of equipment change control plans and qualification/validation test protocols
  • Assist in the review of completed test documentation as a member of Site Validation Review Board to ensure compliance with test procedures and cGMPs
  • Work with appropriate departments and personnel to resolve validation testing issues
  • Advise other departments on SOPs related to validation projects
  • Maintain 100% on time training
  • Execute assigned jobs and tasks according to schedule prepared by Engineering Planning
  • Achieve Execution Group performance metrics
  • Complete other special projects and assignments as required
  • Comply with all regulatory, corporate, and site quality system procedures, especially safety and cGMPs
4

Computer Systems Senior Validation Engineer Resume Examples & Samples

  • Responsible for validating, at a minimum, Automation systems consisting of Batch Execution Systems, Enterprise Systems, Laboratory Equipment, Data Historian (OSI Pi) and a Reporting system in conjunction with the site CSV CQV team
  • Manage a team of contractors where required to deliver to project timelines
  • Coordinating and monitoring the validation/project phases and informing management of project progress
  • Creating and executing protocol test scripts in accordance with cGMP, regulatory requirements, the Computer System Validation Master/Project Plan, and Policies, Procedures & Guidelines to ensure robust tested systems, which are fit for use
  • Assisting in audit preparation and presentation of the above systems for internal, vendor and regulatory audits (e.g. HPRA and FDA)
  • Providing regulatory guidance and support in the management of system upgrades, changes and general validation challenges, and providing support in identifying the need for creation/updating operating procedures or templates
  • Support execution of all CQV deliverables
  • Generate and ensure timely approval of all Commissioning and IOQ Final Reports for systems
  • Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, Q9)
  • Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)
5

Senior App Validation Engineer Resume Examples & Samples

  • Develop and support application integration testing for all global regions that internet apps are offered in
  • Integrate with vehicle, business, IT and application teams to determine their individual testing requirements
  • Improve application quality using the plan-do-check-act cycle
  • Work in a collaborative environment
  • Attend daily development stand up meetings
  • Actively triage defects for permanent resolution
  • Review and provide feedback on product requirements
  • Assist with automation scripts
  • Participate in day-to-day discussions with Product Management, Development, and Program teams to drive product improvements
  • Support application certification efforts encompassing requirements for user experience, driver distraction, legal, and security
  • Provide back up SME support for peers as needed
  • Five to seven years of industry experience
  • Bachelor's Degree in Electrical Engineering, Computer Engineering, or related field or equivalent work experience
  • Ability to travel internationally to support global efforts as needed
  • Strong background with testing tools such as ALM and Jira
  • Strong ability to author and update test-cases
  • Good understanding of Java Enterprise Edition (JEE), Android, HTML 5, JavaScript, and IOS
  • M.S. degree in Engineering/Information Technology or equivalent work experience
  • Working knowledge of testing automation
  • Experience testing mobile and vehicle applications
  • Experience with wireless (Wifi, Bluetooth and Cellular) systems
  • Experience with unit testing tools
  • Experience working in AGILE enviornment
  • Ability to learn specific logging tools quickly
6

Senior Software Engineer Solution Validation Resume Examples & Samples

  • Execute Functional, interoperability, Multi-D Scale and Performance, and customer use test cases. Track test cases and results, Raise, prioritize, and verify defects and fixes
  • Pro-actively seek feedback from Marketing, Account Teams, and Product marketing , TAC groups to continuously improve to Test coverage, execution and automation
  • Strategize Test plans for multi vendor environment and optimize test coverage. -Execute, Develop and maintain of Multi-D profile scripts for test automation
  • Reproduce customer issues CFD in System Test and improve the quality of the product and deployment
  • Responsible for continuous improvement of quality, process, and optimizing the test beds and be the champion of Campus product quality. -Strong Technical Back round on Layer 2 Technologies such as STP, MSRT, RSTP, VLANS, .1BR, VxLAN Technologies
  • Strong Technical exposure on L3 Routing [ BGP, OSPF] and Security Technology [ ACL, Dot1x, Radius and IPsec] features
  • Experience in large scale automation of Multi-D Feature set in TCL, Perl or Python
7

Senior Computer System Validation Engineer Resume Examples & Samples

  • Participate in the development, implementation, execution and adherence to validation procedures and methods related to computer systems validation (CSV)
  • Preparation, review and issuing of CSV documents as they related to computer systems
  • Author, execute, perform, summarize CSV documents: Validation Plans, User and Functional Requirements, Design Specifications, Risk Management Plans, Installation/Operational/Performance Qualification Protocols, Traceability Matrices, Final Reports, Deviation Handling
  • Identify computerized systems validation needs through assessments and integration with IT Project Management Framework
  • Support change control activities, deviations and SOP’s for computer systems
  • Review and approve the relevant documents on validation processes
  • Ensure that the Validation / Qualification and quality systems are working in accordance with any changing and current regulations
  • Participate in the development of Validation methodologies in accordance with applicable Quality/Regulatory requirements and industry best practices
  • Work closely with IT, Business, Regulatory Affairs, and Quality to develop, coordinate and execute Validation documents and strategies
  • Manage and execute decommissioning activities for retired or end-of-life equipment
  • Author/revise SOPs related to validation/qualification, operations, IT, as they relate to CSV
  • Represent Validation in cross-functional team meetings/projects as required
  • Effectively communicate with Leadership and all departments regarding Validation activities
  • Participate in conducting root cause analysis, deviation resolution (CAPA), and effectiveness checks for CSV
  • Organize and maintain validation documentation
  • Apply Good Manufacturing Principles in all areas of responsibility
  • Play an integral role in Practical Process Improvement (PPI) program
  • Recommend acceptance of the computer system, as determined from the CSV tasks performed on the system
  • Analyze data outputs from CSV activities in order to determine acceptability of system for GxP business use. Recommends actions to be taken if the software is not accepted
  • Bachelor’s Degree in Engineering, Science, or related field
  • Must have a minimum of 6-8 years experience in an FDA regulated industry
  • Experience in a manufacturing or R&D operation a plus
  • Through knowledge of cGMP and FDA regulations and Annex 11
  • Ability to impact and influence people/areas in matters related to CSV and GxP compliance
8

Senior HW Validation Engineer Resume Examples & Samples

  • 8+ years of industry experience
  • Hands-on experience in prototyping, bring-up, debugging, verification and manufacturing support for embedded systems
  • Strong expertise in test script development Python. LabVIEW experience would be plus
  • Must be proficient in analog and digital circuit debug. RF would be a plus
  • Strong fundamental understanding of high speed as well as low power measurement
  • Knows how to use our thermal chambers, power analyzers, oscilloscopes and RF test equipment
  • Proficient with data analysis using tools such as Python, R, Excel, LabVIEW, Minitab…
  • Proficient with debugging tools and techniques for embedded systems
9

Senior / Hardware Validation Engineer Resume Examples & Samples

  • BSEE required, MSEE preferred with more than 2 years preamp experience
  • Hands-on experience in post silicon validation and debug
  • Good working experience in software programming for test automation
  • Capable of test plan development and setup implementation
  • High technical competence and be able to adapt to a dynamic challenging work environment
  • Working knowledge of using lab equipment including high speed oscilloscopes, spectrum analyzers, network analyzers and waveform generators
10

Senior CPU Validation Software Engineer Resume Examples & Samples

  • Extensive software development experience with ‘C’ and knowledge of low level assembler programming languages
  • Experience of complex CPU architecture features and their corresponding interactions, especially relating to caches, MMU, SMP, coherency and out of order execution
  • Experience of developing and debugging low level software at the architectural level
  • Desire to push the boundaries of validation
  • Experience of development of random instruction generators for system validation, also known as random instruction sequence (RIS) tools
  • Post silicon validation experience and experience with hardware validation platforms such as FPGAs, emulators and testchips and associated waveform viewing tools for debug analysis
  • Knowledge and use of ARM instruction set architectureKnowledge of micro-architectural features and implementations
  • Experience in creation of directed validation/regression tests either from problem investigation or abstracted analysis
  • Experience with scripting languages such as Python, Perl and TCL in the context of medium to large projects
  • Experience of the software development lifecycle and revision control systems such as Git
  • Experience of OS kernel concepts, including ARM architecture support
11

Senior / Hardware Validation Engineer Resume Examples & Samples

  • Responsible for post-silicon validation of Marvell's preamp products
  • Responsible for conducting functional and performance validation, power analysis and performing electrical characterization across process, voltage, temperature corners
  • Provide onsite customer support to understand and debug issues
  • Support customer meetings and manage closure of action items
  • Responsibilities also include test plan development, test automation and test report generation; issue debugging and resolving
  • Strong understanding of both analog and digital design
  • Proficient in C# programming, Python and Matlab scripting
  • Attention to details, strong team player and self motivated
12

Validation Engineer Senior L SHD Resume Examples & Samples

  • It would be preferred if you have an ISTQB® Certification – Foundation Level, development background
  • You must be fluent in English and Spanish
  • We would like someone to join our team who is QA-minded, positive, a problem-solver and fast learner, rigorous, detailed-oriented, customer-oriented, and able to work in a diverse environment, a team-player, curious, autonomous and responsible
  • You must have a Degree in Computer Science, Software, Electrical Engineering, Telecommunications, Information Technology or a related field
  • We are looking for someone with 4 - 5 years of experience in QA related activities
13

Senior Engineer, Validation Resume Examples & Samples

  • Preparation and execution of validation protocols involving facilitates equipment, utilities and associated automation
  • Preparation, review and approval (as required) of SOPs, validation deviations, change control, validation summary reports and associated documentation
  • Management and co-ordination of validation activities with internal departments, external contractors and suppliers
  • Prepare and deliver cross functional training in validation methodologies, protocols and related procedures to facilitate validation activities
  • Primary point of contact for validation related issues arising during validation activities (including protocol execution)
  • Investigation of deviations / non-conformances to determine [potential] impact on product quality, validation status and associated compliance requirements
  • Partners with functional departments to perform deviation root cause analysis and formulate corrective / preventative actions (CAPA)
  • Performance of risk and impact assessments associated with validation activities, deviations and changes
  • Provides support to commissioning activities, including review of commissioning plans, procedures, turnover packages etc. (as required)
  • Performs final review of test data / reports to ensure conformance with established specifications and related standard operating procedures
  • Provide guidance on validation requirements and expectations to validation engineers and project team
  • Represent validation as a subject matter expert (SME) in all project phases (including commissioning and qualification execution)
  • Represent the validation program and designated validation activities during inspection by regulatory agencies and Biogen Quality / Regulatory functions
  • Review of technical documents / reports to ensure that validation activities are consistent with current company, industry, regulatory requirements, and current technology
  • LI-POT4
  • 5-8 years experience in a Validation/Quality role in a biopharmaceutical manufacturing environment. Large scale project experience
  • Thorough knowledge of biotechnological technologies, processes and clean utilities
  • Demonstrated proficiency in Good Practice requirements (GMP, GEP) as well as biopharmaceutical industry regulations and norms as they relate to validation
  • Strong technical writing and communication skills in English. German an advantage
  • The ability to take pragmatic and compliant decisions
  • Highly motivated to take ownership and responsibility for assignments
  • Ability to take the initiative with minimal supervision
  • Proficiency in MS Word, MS Excel and MS Project
14

Senior Subsystem Validation Engineer Resume Examples & Samples

  • Work with system safety to create VCRI to map safety requirements to appropriate validation area
  • High level of organizational skills - Able to manage multiple projects across multiple programs
  • Able to work within a team of engineers and communicate issues and testing results effectively
  • High level analytical ability where problems are unusual and complex
  • Knowledge of safety critical software and systems
15

Senior Engineer, Validation Resume Examples & Samples

  • Identifying and defining requirements for test hardware necessary to validate silicon and test new features (PCBs, ICs, evaluation platforms, test equipment, etc.)
  • Debugging test setups including issues with test PCBs, software, firmware, and test equipment
  • Writing tests to exercise and validate various areas/functionality of a chip (memory, routing fabric, timers, etc.) for chip bring-up, testing, and debugging
  • Developing low-level firmware drivers and firmware tests for post-silicon validation and new silicon bring-up and in support of the Design and Firmware Teams
  • Interfacing with the Hardware and Firmware Teams to confirm expectations/understanding of chip operation and ensure validation requirements are met
  • Creating documentation such as test plans, test reports, how-to guides, and best practices
  • A minimum of BSEE in Computer Engineering or Computer Science and 4-7 years of experience
  • Experience with USB 2.0 and/or HSIC testing, validation or verification
  • Experience with C/C++ and Python scripting
  • Experience with PCB schematic design
  • Familiarity with microcontroller architectures
  • Familiarity with interfaces commonly found on microcontrollers (SPI, I2C, I2S, USB)
  • Interface with and support cross functional teams such as Design, Product Test Engineering, Applications, and Firmware
16

Senior Validation Engineer, Product Lifecycle Resume Examples & Samples

  • Support Engineering Change Order implementation activities including scrap analysis, material disposition, update work instructions and test requirement changes
  • Review existing validation reports and identifies gaps for compliance. Develop strategies and plans to close the gaps in an efficient and technical manner
  • Develop and communicate expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products
  • Participate as an active member on new product development teams
  • Monitor and drive corrective action and continuous improvement activities that directly impact performance measures
  • Provide day-to-day support to development, engineering and manufacturing for design control planning and design transfer activities
  • Participate in project management meetings as Validation representative determining validation requirements, as needed
  • Collaborate and provide consultation to other departments performing validation activities
  • Ensure validation program meets requirements of FDA (21 CFR Part 11) and ISO
  • Provide guidance and supervision to junior staff
17

R&D Senior Validation Engineer ICS Resume Examples & Samples

  • You must have an engineer diploma in Information Technology or Computer Science
  • To succeed at this job, you must have at least 5 years' work experience in Validation/Integration/QA
  • You must have customer site experience (SW/HW Integration)
  • We are looking for someone with excellent knowledge in validation methodologies, processes and tools like HP Quality Center. Someone who is independent in test definition
  • You must have experience in web application testing. Experience with scripting language for automatic tests
  • You must have good knowledge of SQL and Database servers
  • You must have good understanding of web technologies and applications servers. Understanding of web technologies & protocols (HTTP, HTML/XML, Json…)
  • We would like someone to join our team who excels in problem solving, who has a very good analytical mind, and is able and willing to learn
  • You must be detailed-oriented, able to cope with and manage multiple tasks
  • You must have a solid understanding of data communications protocols/technologies including HTTP, SSL
  • You must have experience with network communication protocols, configuration and management, experience with administration of TCP/IP based network
  • We are looking for someone who is experienced in administration, configuration and tuning of application servers (IBM Websphere, JBoss/wildfly, Tomcat) and Windows 2008 server (AD, DNS). Experience in the following tools : Jenkins, Mercurial, Redmine, Sonar, Fortify,SOAP UI
  • You must be Fluent English
  • You must be willing to travel worldwide for workshops, integration and deployment in customer premises (short/medium duration)
18

Senior HW Validation Engineer Resume Examples & Samples

  • As Member of the HW validation team should have knowledge of and perform duties associated formal Electrical Validation Testing (EVT)
  • Power Delivery Network (PDN) testing and analysis, VRM circuit understanding and functional characterization
  • Knowledge of System communication bus (I2C, SPI, SMBus) protocols and to perform testing/characterization as part of EVT plans
  • HW Validation Plans creation and reports generation
  • Supporting Failure Analysis
  • Experience performing the following validation functions
  • BSEE and 10+ years of experience; or an MSEE and 7+ years of experience
19

Experience Validation Senior Engineer Resume Examples & Samples

  • Engage technical contacts within the advanced engineering and development teams, to develop and execute use cases, reproduce experience based issues, communicate status and determine appropriate test coverage
  • Lead a team of testing engineers executing experience based audits
  • Drive experience based test processes and methodologies across engineering
  • Establish clear lines of communication between the engineering and validation team
  • Maintain a library of tests to support current and next generation solutions
  • Review test case historical performance to eliminate low-value tests and improve tests resulting in false failures
  • Identify tools and software required for testing
  • Gather additional test requirements from external teams and incorporate the feedback into test cases
  • Be the primary experience validation interface to local engineering teams
  • At least a BS in a Computer Science or related field
  • Minimum 5 years experience as a test engineer, designing, authoring, and executing test cases
  • Experience in developing and implementing testing strategies for solution based projects
  • Experience in leading test engineering experience teams
  • Proficiency in both waterfall and agile development methodologies
  • Experience writing use cases from technical requirement documents
  • Proficiency in writing and executing user experience based use cases
  • Experience working with international teams
20

Senior Manufacturing Validation Engineer Resume Examples & Samples

  • Direct and coordinate new product introduction activities to assure all functional areas are involved to the extent specified in the product development procedure
  • Collaborate with design engineers to improve the manufacturability of current designs
  • Research and develop new processes and manufacturing systems to improve quality, productivity, and reduce operating costs
  • Lead, develop, and mentor manufacturing engineering support staff as required
  • A minimum of 5 years of software engineering experience in a manufacturing environment
  • A minimum of 2 years of project management experience
  • A minimum of 2 years of process improvement experience
  • Previous experience using Siemens PLM software
21

Senior Engine Development & Validation Engineer Resume Examples & Samples

  • Tools and processes
  • Lead engine development validation activities
  • Degree in mechanical engineering, electrical engineering, or
  • Ability to solve problems through test design, execution,
22

Senior Software Fpag Validation Engineer Resume Examples & Samples

  • Write test cases in Verilog/VHDL to verify key features during software development
  • Software product benchmarking compared to competitor
  • Responsible for new FPGA device evaluation
  • Responsible for Lattice software product validation and verification
  • Responsible for root cause analysis on quality of results (QoR)
  • Responsible for static timing analysis (STA) on QoR benchmarking
  • Responsible for synthesis tool evaluation and verification vs B35 party vendor
  • Provide QA testing report and analysis report
  • Skill in digital logic circuits design with FPGA application
  • Skill in Verilog/VHDL coding
  • Familiar with FPGA technologies, preferably Lattice
  • Experience in applying EDA tools such as Diamond, ISE/Vivado or QuartusII
  • Experience in synthesis tools application as well as simulation tools
  • Experience in script language (Python, Perl, Tcl or Shell and etc.)
  • Understand Lattice FPGA architecture as well as competitor’s
  • Well known the process flow of EDA tools for FPGA
  • Well known EDA SW validation method and process
23

Senior Engineer, Validation Quality Resume Examples & Samples

  • Development, execution and critical review/approval of software validation and equipment qualification protocols and reports
  • Critical review/approval of equipment and design changes as a partner with R&D labs and teams in the design or testing of safe and effective medical devices
  • Root cause analysis investigation for equipment and related software issues, and component and device non-conformances
  • Train, coach, and guide teams on routine procedures in area of expertise
  • May also provide technical quality support for design qualification, design transfer, activities for Regulatory submissions, development and implementation of design control documents, and approval of product/process changes, as needed
  • Minimum of 4 years Validation, Quality or Manufacturing experience is required
  • Knowledge of software validation and equipment qualification methods and principles in the medical device or a similar regulated industry is required
  • Quality Engineering experience in medical device product development is preferred
  • Basic understanding of statistical techniques is required
  • Good understanding and knowledge of Quality Engineering principles, theories, and concepts is preferred
  • Must have strong documentation skills
24

Senior Validation Engineer Radar Applications Resume Examples & Samples

  • Perform IC validation, characterization and qualification tasks as member of a larger, multicultural and multisite team
  • Evaluate CMOS circuit performance, in digital, analogue and Radar/high frequency domain
  • Use his/her Radar or high frequency know how to contribute to product performance evaluation
  • Support customer design in efforts and customer complaints
  • Support next generation Radar design perfection and specification
  • Contribute to BL IDA PE tasks such as Complaint Handling, Sustaining Engineering etc, with strong focus on Radar Domain
25

Senior Qualification / Validation Engineer Resume Examples & Samples

  • BS in Mechanical, Chemical, Electrical Engineering, Computer Science or equivalent
  • 5 - 10 years of CQV experience in the life sciences industry
  • Knowledge of FDA and EMEA regulations (21 CFR Parts 210/211/810; ISO 13485, etc.)
  • Experience in supervising and/or working in sub-teams of technical personnel
  • Six Sigma Certification
  • SME by Industry: Sterile, OSD, Biotech, Medical Device
  • SME by Equipment/Systems: Distributed Utilities, Process Utilities, Manufacturing Equipment, Packaging Equipment, HVAC, BMS, BAS
  • SME by Validation activity: Commissioning and Qualification, Process Validation, Cleaning Validation, Computer System Validation, Methods Qualification and Validation
26

Senior Engineer, Verification & Validation Resume Examples & Samples

  • Bachelor degree or above major in computer science, electrical engineering, mechanical engineering or closely related discipline
  • Bachelor 5+ years, Master 3+ years working experience in product development and testing
  • Proven ability to test complex hardware or software product, professional in product test case design and planning
  • Product design and test experience in medical devices
  • Demonstrated technical leadership in project execution and product integration and test activities
  • Good English communication skills both in oral and writing, global project experience will be plus
27

Senior Systems Validation Engineer Resume Examples & Samples

  • Planning, conducting, and documenting the validation for the project
  • The validator:shall develop a system understanding of the (sub-)system within the intended environment of application
  • Develop a validation plan and specify the essential tasks and activities for (sub)-
  • Evaluate that the correctness, consistency and adequacy of verification and testing is
  • Performed
  • Check the correctness, consistency and adequacy of test cases and executed tests
  • Ensure all validation plan activities are carried out
  • Review and classify all deviations in terms of risk (impact) and records and submits the
  • Capture deviations from the validation plan
  • Carry out audits, inspections or reviews on the overall project (as instantiations of the
  • 8-10 years’ experience in system engineering
28

Senior Validation Process Engineer Resume Examples & Samples

  • Drive Design Assurance support and oversight for product development activities
  • Ensure product development team(s) follow critical procedures & validation processes
  • Ensure risk management tools are employed and evolving (HARA, DFMEA, PFMEA). Oversee and ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards. Promote a “safe culture”
  • Ensure requirements traceability and flow from customer requirements into L1/L2 specs
  • Ensure validation targets, pass/fail criteria & procedures exist and are adhered too
  • Establish standard work for validation & verification process assessments & adherence
  • Ensure compilation, storage & reuse of critical validation history documentation
  • Ensure robust, proactive validation reviews by leveraging standard work & best practices
  • Ensure post sales assessments are conducted & lessons learned part of future programs
  • Perform independent assessments of new product development programs
  • Review and approve critical design & validation process milestones
  • BS Degree in Mechanical or Electrical Engineering or equivalent. MS degree preferred
  • Minimum 7 years of experience in product validation and/or product quality
  • Strong acumen for industry best practices in development, testing & manufacturing
  • Experience in establishing and implementing quality metrics for product development
  • Extensive use of the Microsoft Office suite. Experienced with PPT & Excel
  • Strong communications skills, problem-solving & ability to influence required
29

Senior Hardware Fpga Validation Engineer Resume Examples & Samples

  • Work in a team to define and build functional tests for custom hardware designs, including system validation, integration and manufacturing
  • Work in a team to define and build test infrastructure, including FPGA/emulator infrastructure
  • Work with software driver and internal logic design teams to define and develop test hardware and strategies for accelerators
  • Deploy and maintain tests and procedures to meet significant quality, reliability, and service level requirements in a cloud environment
  • Working with and directing ODM/OEM manufacturers and partners in test and qualification
  • Collaborate closely with other product groups
  • Bachelors required, EE or Computer Engineering MS desired
  • 1+ year FPGA, ASIC or Silicon design, dev or validation
  • 5+ years of experience developing tests and test infrastructure for hardware designs
  • 5+ years of experience with developing and debugging software to take advantage of new silicon
  • Hardware validation experience in all stages of a release cycle (design, implement, and test) with ability to cover multiple job roles
  • Experience with FPGA designs and high-speed 10G/25G/50G SERDES a plus
30

Powertrain Mechatronics Senior Validation Engineer Resume Examples & Samples

  • Support a fleet of prototype medium and heavy duty trucks, focusing on Powertrain Mechatronics controls and related systems
  • Technical resource in Portland for proprietary automated manual transmission programming, functions, diagnostics and troubleshooting
  • Coordinate special tests on Powertrain Mechatronics systems in-vehicle
  • Collaborate with corresponding teams in Detroit, Stuttgart and Portland and participate regularly in meetings to discuss validation planning and activities, open issues and current project work
  • Mentor junior group members and assist with diagnostics and performance issue investigation
  • Understanding of CAN, XCP, J1939 and UDS communication protocols
  • Motivated, self-starter, proactive
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Senior Systems Validation Engineer Resume Examples & Samples

  • Minimum 8 years’ industry experience in product development environment required with a Bachelors in Electrical Engineering or equivalent degree
  • Working knowledge of IEC 62304 for Software, IEC 62366 for Usability, and IEC 60601-x series for Safety and EMC Tests
  • Proven ability to perform problem solving and troubleshooting required
  • Strong attention to detail required
  • Demonstrated leadership role in product development evnrionment including ability to provide guidance and direction to less experienced technical personnel required
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Senior Engineer, Product Validation Resume Examples & Samples

  • Design with RTL coding in Verilog and VHDL and Verification of RTL
  • Possess an in-depth understanding of hardware architectures, system level IC design implementation, knowledge of how to create end use scenarios
  • Optimizing code for FPGA architectures
  • Experience using Simulation (ModelSim) and Synthesis (Synplicity) tools
  • Basic knowledge of embedded processors such as ARM Cortex-M3, and familiarity with AMBA protocols APB, AHB, AXI, ACE
  • Hands on troubleshooting skills for digital logic on PCB's using oscilloscopes and digital analyzers
  • Knowledge in scripting languages such as TCL and PERL is desirable
  • Experience in system level designs using mixed signal components, NVM (non-volatile memory) highly desirable
  • Knowledge of board level design and debug
  • Embedded software C/C++ is also a plus
  • Familiarity with system modeling and RTL verification is also a plus
  • Hands-on experience with any two of the following industry protocols and interfaces
  • IEEE 802.3 (Ethernet with MII/RMII/GMII/RGMII/SGMII/XAUI)
  • DSP (FIR/IIR)
  • IEEE 1149.1 (JTAG)
  • PCIe 2.0
  • DDR/LPDDR/DDR2/DDR3 SDRAM memories
  • USB 2.0
  • Spacewire
  • JESD204B
  • SRIO
  • MilStd1553
  • QDR memories
  • Prefer some design experience with Microsemi (formerly ACTEL) FPGAs
  • Experience with emulation flows is a plus
  • Protocol knowledge and emulation experience with the following is desirable for a future upcoming project: SATA, Interlaken, OTN, Fiber Channel, RXAUI, 10GBASE-KR, HiGig/+/II, SDI-SD/HD/3GHD, Display Port, QSGMII, CPRI, MIPI
  • Minimum requirements: M.S. degree with 4+yrs of experience
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Senior Hardware Validation Engineer Resume Examples & Samples

  • Validate PCS and PMA blocks of transceivers
  • Develop RTL test designs and firmware to validate transceivers
  • Develop scripts for test automation and post processing
  • Define test methodologies for high speed serial IO measurements
  • Ensure transceiver meets electrical compliance requirements for protocols such as PCIe, Backplane Ethernet
  • Bachelor's Degree in Electrical Engineering or Computer Science or related fields with 5+ years of work experience with high speed test equipment such as scopes, BERTs and Analyzers for characterizing transceivers or MS in EE, CS or related fields with 3+ years of work experience with high speed test equipment such as scopes, BERTs and Analyzers for characterizing transceivers
  • Experience in Perl/Python/C++
  • Experience in Verilog/VHD
  • Familiarity with FPGA design flow is a plus
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Senior Digital Validation Engineer Resume Examples & Samples

  • 4) Strong experience in validation automation
  • 5) Experience in digital and mixed signal designs
  • 6) Experience in “C” based Software driven validation methods
  • 7) Hands on experience in characterization of digital interfaces like SPI, MIPI CSI2 and digital IOs
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Senior FW Hardware Validation Engineer Resume Examples & Samples

  • Work as part of the management firmware team (MFW) and hardware engineering team defining test requirements and test plans and verifying Cavium ASIC meet all relevant Ethernet standards for ASICS. This testing will cover the following Ethernet layers, PMD/PCS and MAC
  • There are Ethernet requirements that are both meeting the standards for the various Ethernet layers and error handling conditions
  • Help assemble required tests and test requirements into a test plan. The individual will then work with the MFW, HW engineering and PQA teams to make sure the appropriate tests are completed and meet the Ethernet requirements and the expected ASIC performance
  • Understand the Ethernet requirements from a protocol layers standpoint, IP, TCP-UDP, DHCP, DCBX, LLDP
  • Define and run tests that stress different protocol layers and determine error conditions
  • Work as part of the management firmware team to define and implement test and debug firmware for internal use by hardware engineering and system test teams. The job requires the ability to modify or develop existing firmware to create the appropriate test platforms for engineering test teams
  • The job also requires being able to debug firmware to correct issues found in test
  • As an Ethernet test engineer, you will have the opportunity to work in a dynamic group which influences and guides Cavium’s technical teams. Responsible for defining the test plans for various Ethernet ASIC, systems, and interfaces
  • Proactively file for IP disclosures related to your work, develop and maintain high quality specifications, keep abreast of technical developments in the field of high performance Ethernet
  • As an Ethernet Verification Engineer you will be directly responsible for all aspects of functional validation for Ethernet PMD/PCS/MAC blocks. You will focus on validation of both the code and hardware performance of these blocks
  • Understand the Ethernet ASIC architecture and the controlling management firmware. You will develop test firmware to validate individual layer performance in both normal operating conditions and in error conditions
  • Own and debug failures and root-cause problems. This role will require closely working with MFW and RTL engineers of the blocks being validated
  • Strong background in C and one assembly language, prefer MIPS
  • Excellent communication skills to interface internally and externally with all levels of the organization and to participate in problem solving and quality improvement activities
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Senior Product Engineer Validation Resume Examples & Samples

  • Wafer level characterization of CMOS imaging sensors
  • Determines how to test product features
  • Debugs initial silicon and validate design features
  • Determines root cause of problems (process or design-related)
  • Validates automated silicon verification with bench testing and measurements
  • Correlates test results generated in Color Probe
  • Explains rational of test in probe and helps determine most effective method to implement test with coverage, potential overkill, and test time being the biggest factors
  • Determines test algorithms to target specific fail mechanisms
  • Prepares detailed descriptions for tests required during design validation cycle
  • Minimum of five years plus of industry experience
  • Design/System Level validation of CMOS imaging products
  • BSEE, related field or equivalent work experience
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Senior Hardware Validation Engineer Resume Examples & Samples

  • Work with design teams to develop validation plans
  • Develop automation frameworks and test tools
  • Provide functional verification of electrical subsystems
  • Work with design team to debug issues
  • Report validation status
  • Travel overseas to China to support factory builds
  • Experience in failure analysis and troubleshooting skills in a laboratory environment
  • Experience with test automation with background in scripting
  • Experience working in a laboratory environment
  • Understanding of EE fundamentals
  • This position will require estimated 20% travel to China to support factory builds
  • Experience with video, cameras, audio, power supplies, I2C/SPI/UART buses, and highspeed electrical signal characterization
  • Experience with battery powered, wireless, embedded HW/SW consumer devices
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Senior Hardware Validation Engineer Resume Examples & Samples

  • Knowledge of mass storage, SSD (Solid State Drive)
  • Strong coding experience in C and assembly is required
  • Prior experience with ARM processor is needed
  • Familiar with typical lab tools: emulator, oscilloscope, logic analyzer, and bus analyzer
  • Familiar with SATA interface
  • Familiar with DDR interface is a plus
  • Familiar with PCIe/AHCI/NVMe interface is a plus
  • BS in electrical engineering or computer engineering, and at least three years professional experience. MS preferred
  • Plan and create the validation test environment, design, development, and maintaining validation firmware and scripts
  • Work with SOC designers to thoroughly validate and test functionality and features of SOC chips
  • Isolate, debug, and report problems and issues on SOC silicon
  • Work with FAE engineers to answer and resolve the customer questions and problems
  • Work with ATE engineers to develop and debug the ATE tests for the production
  • Provide validation documentation to customers, application engineers, and filed application engineers
  • Develop firmware code for embedded validation system
  • Perform SOC block validations including PCIe/NVMe/SATA/DDR/Peripherals functions and new features
  • Develop test software/application
  • Develop regression test
  • Provide supports to internal and external customers
  • Provide supports to existing SSD projects
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Senior System Validation Tools Engineer CSI Resume Examples & Samples

  • Develop automation for the validation and qualification of server hardware platforms and components
  • Design and develop test cases for server hardware validation
  • Bachelor’s degree required. MS BSEE or BSCE desired
  • 2-10+ years of experience developing scripts, utilities or applications. Ideally for server hardware components
  • 2-10+ years’ experience with complex programming languages such as C#, C++
  • 1+ year experience in test, diagnostic or validation
  • Experience with scripting languages such as PowerShell or python
  • Familiarity with Intel X86 computer architecture. Specifically, an understanding of the basic HW and SW components and how they interact
  • Self-motivated individual, must be able to work collaboratively in fast paced team environment with competing priorities
  • A passion for problem solving (logic and reasoning)
  • Knowledge of Microsoft Team Foundation Server
  • Experience in deploying Windows based Operating Systems