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