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Senior Hardware Engineer Resume

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Los Angeles, CA

SUMMARY

  • Electrical engineer with 9+ years of experience in class - 3 medical device industry.
  • Primarily focused on component engineering, hardware board designing and testing, design quality, reverse engineering and sustaining project engineering.
  • Extensive experience in Product lifecycle management, verification and validation, medical quality management systems and regulatory standards.
  • Board designing(analog and digital), analysis and testing
  • Product sustaining engineering and obsolescence management
  • Component selection for design requirements
  • Bill of material (BOM) management and cost reduction
  • Engineering and design verification testing and report generation
  • Class 3 medical device documentations (Design input, Output, Risk management, Design verification and validations) per FDA requirements(QSR)
  • Good knowledge on FDA 21 CFR 820,IEC 60601-1, ISO 14971 & ISO 13485 standards
  • Test fixture designing and qualifications
  • Cable design for RF frequency surgical applications and verification
  • CAPA/NCR review and execution
  • Equipment validation(IQ,OQ and PQ)
  • PCN analysis and alternate source selection for design requirements
  • Schematics capture, Symbol creation, BOM creation, PCB/PCBA designing
  • Coordinating with Component manufactures and PCB/PCBA suppliers
  • PCB/PCBA component verifications, DFx review and support
  • Good knowledge on quality regulations- RoHS, WEE, REACH
  • RoHS component selection and qualification Per JEDEC and iNEMI standards for medical devices
  • Exposure to more than 6000 COTS components over 100 manufactures
  • Process improvement and waste removal using expertise in Lean Six Sigma
  • Cross functional coordination and issue resolution
  • Excellent analytical and problem-solving abilities

TECHNICAL SKILLS

CAD Tools: Cadence Allegro, Orcad Capture, Concept HDL

Simulation Tools: LTspice, Pspice, Timing Designer

PLM Tools: eCentral, Agile, cPDM

Part lifecycle management: Arrow risk manager, Total Part plus

Schedule management: MPP

PROFESSIONAL EXPERIENCE

Senior hardware engineer

Confidential, Los Angeles, CA

Responsibilities:

  • Selection of cable materials and wire gauges
  • Cable routing technique selection for various signal lines
  • Design analysis for noise immunity for low voltage, low current sensor signals and high frequency RF signals
  • Circuit designing for signal conditioning and amplification.
  • Design trace matrix, Risk management, DFMEA, design input and output file creation
  • Component design verification plan, protocol and report creation and execution
  • Testing as per standards IEC-60601-1, 60601-2-2, ANSI/AAMI EC53
  • Critical to quality (CTQ) parameter identification for components(PCB, Shaft, electrodes,, sensors) and functions(ECG, navigation, RF ablation, irrigation, pacing, force and temperature measurements)
  • PCB, cable failure investigation and root cause identification
  • CAPA review and execution
  • Test jig qualification (IQ, OQ, PQ)
  • Engineering testing and characterization, signal acquisition and generation using LabVIEW and analysis
  • Implementation of ECOs (Engineering Change Orders)
  • Cross functional (quality, regulatory, document control) team coordination

Lead hardware design engineer

Confidential, Redmond, WA

Responsibilities:

  • Selection of RoHS compliant components meets design requirements
  • Redesigning of functional blocks where interchangeable RoHS parts are not available
  • Design analysis for redesigned boards
  • Qualification of RoHS part as per iNEMI and JEDEC standards and Tin whisker risk assessments
  • Lead free solders analysis and Manufacturing compatibility analysis
  • BOM management and Inventory managements
  • Schematic, PCBA and BOM updates and verification
  • Perform Design Review and Design Verification
  • Product Failure Mode, Effects and Criticality and Analysis
  • Solder dipping of components that are prone to tin whiskers
  • Implementation of change request, Change orders, and component level design documents
  • Lead the team of 12 and completed the project in 18 months

Lead hardware component engineer

Confidential

Responsibilities:

  • Selection of components as per design document
  • Board redesign and analysis
  • Schematic, PCBA and BOM updates and verification
  • Creation of electrical requirements specification, Electrical development plans
  • Board bring up and trouble shooting
  • PCBA component verification
  • Determination of Part obsolescence and replacement
  • Tin whisker and reflow assessments, Solder reflow analysis and RoHS status check
  • Implementation of request for design changes (RDCs) and MOLs
  • Create change request, Change orders, Drawings and MEPs
  • Design change to reduce cost
  • Engineering Bill of materials change update and PCB/PCBA revisions
  • PCB/PCBA production and PPAP/IP/FAI supports
  • Create/revise/update design documents and release in client system per client’s process
  • Supplier/manufacturer interaction for custom part changes

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