Senior Hardware Engineer
SalaryNo pay range posted
LocationTarrytown, New York, United States
SenioritySenior
Experience10+ yrs
Company size1,001–5,000 people
PostedSep 9, 2026 · 1mo ago
Verified live20h ago
At a glanceSummarised by Seekless from the posting.
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
Skills
MCU
FPGA
PCB Design
Ethernet
USB
SPI
I2C
CAN
Windchill
Agile PLM
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
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.
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