Senior Hardware Engineer - Medical Devices
Egnite HR TECH
Senior Hardware Engineer – Regulated Industry
Location: Tarrytown, NY, USA
Visa: USC/GC/H1B/OPT
Must-Have Skills
- 7+ years of experience in Hardware Development
- Analog, Digital & Mixed-Signal Design,
- Experience with signal integrity techniques and layout constraints.
- MCU, FPGA, Sensor Interface Design
- Power Electronics, Battery-Powered Devices, DC-DC Converters
- High-Speed PCB Design (Ethernet, USB, SPI, I2C, CAN)
- PCB Design, DFM, DFT, SI/PI Analysis
- Hardware Verification & Validation (V&V)
- Hands on risk Management.
- IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485
- Windchill / Agile PLM
- Interfaces: USB, I2C, SPI, RS232, Ethernet, GSM, Bluetooth, Altium, OrCAD
Preferred Skills
- Prior experience designing medical equipment or IVD systems.
- Experience with motion control systems, motor drivers, and precision sensors.
Key Responsibilities
- Lead 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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