Job Description
Hello Position : Senior Hardware Engineer Medical Devices Location: Tarrytown, NY, USA Employment Type : Contract Must-Have Skills 10+ years of experience in Medical Device Hardware Development Analog, Digital & Mixed-Signal Design 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 CAPA, NCR, Change Control & Obsolescence Management Component Qualification & Alternate Part Evaluation Hardware Verification & Validation (V&V) Risk Management (dFMEA, pFMEA, sFMEA) Requirement Traceability (RTM) IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485 FDA Medical Device Regulations Manufacturing Transfer & Sustaining Engineering Windchill / Agile PLM Preferred Skills IVD / Clinical Diagnostics / Medical Equipment Cost Reduction, VAVE & Should-Cost Analysis Safety & EMC Compliance Testing Supplier Qualification & Product Lifecycle Management Agile / Scrum Project Execution Key Responsibilities Lead 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. Thanks and regards Sonali Silswal Team Lead- Talent Acquisition Email: Contact: LinkedIn : Address: 2591 Dallas Pkwy, Ste 300, Frisco, TX 75034 Website:
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