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Senior Hardware Engineer - Medical Devices

Egnite HR TECH

Senior Hardware Engineer – Regulated IndustryLocation: Tarrytown, NY, USAVisa: USC/GC/H1B/OPTMust-Have Skills7+ years of experience in Hardware DevelopmentAnalog, Digital & Mixed-Signal Design,Experience with signal integrity techniques and layout constraints.MCU, 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 AnalysisHardware Verification & Validation (V&V)Hands on risk Management.IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485Windchill / Agile PLMInterfaces: USB, I2C, SPI, RS232, Ethernet, GSM, Bluetooth, Altium, OrCADPreferred SkillsPrior experience designing medical equipment or IVD systems.Experience with motion control systems, motor drivers, and precision sensors.Key ResponsibilitiesLead hardware design, development, and sustaining engineering activities for regulated medical devices.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.

Vacancy posted 4 days ago
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