Senior Hardware Engineer

Senior Hardware Engineer – Medical Devices

Location: Tarrytown, NY, USAMust-Have Skills10+ years of experience in Medical Device Hardware DevelopmentAnalog, Digital & Mixed-Signal DesignMCU, FPGA, Sensor Interface DesignPower Electronics, Battery-Powered Devices, DC-DC ConvertersHigh-Speed PCB Design (Ethernet, USB, SPI, I2C, CAN)PCB Design, DFM, DFT, SI/PI AnalysisCAPA, NCR, Change Control & Obsolescence ManagementComponent Qualification & Alternate Part EvaluationHardware Verification & Validation (V&V)Risk Management (dFMEA, pFMEA, sFMEA)Requirement Traceability (RTM)IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485FDA Medical Device RegulationsManufacturing Transfer & Sustaining EngineeringWindchill / Agile PLMKey ResponsibilitiesLead hardware design, development, and sustaining engineering activities for regulated medical devices.Drive CAPA, change management, obsolescence mitigation, and product improvement initiatives.Perform schematic reviews, component selection, PCB design reviews, and hardware validation.Execute risk assessments, V&V, compliance testing, and regulatory support activities.Support manufacturing transfers, supplier changes, and cost optimization programs.Collaborate with Systems, Firmware, Mechanical, Quality, Regulatory, and Manufacturing teams.