Senior Hardware Engineer

Sapsol Technologies Inc • Tarrytown, NY

3d

About The Position

This role involves leading hardware design, development, and sustaining engineering activities for regulated medical devices. The engineer will drive key initiatives such as CAPA, change management, obsolescence mitigation, and product improvement. Responsibilities include performing schematic reviews, component selection, PCB design reviews, and hardware validation. The position also requires executing risk assessments, V&V, compliance testing, and regulatory support activities. Additionally, the role supports manufacturing transfers, supplier changes, and cost optimization programs, requiring close collaboration with cross-functional teams including Systems, Firmware, Mechanical, Quality, Regulatory, and Manufacturing.

Requirements

• 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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed