Senior Hardware Engineer

Saxon Global; Village of Tarrytown (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

Saxon Global is seeking a Senior Hardware Engineer to lead the design, validation, and sustaining engineering of medical devices in a regulated environment. You will drive CAPA, change control, obsolescence mitigation, and collaborate across Systems, Firmware, Mechanical, Quality, Regulatory, and Manufacturing teams.

The role requires extensive hardware expertise, V&V capabilities, and experience with Windchill/Agile PLM, with a focus on manufacturing transfers and product improvements.

Qualifications

• 10+ years of experience in hardware engineering.
• Analog, digital and mixed-signal design expertise.
• MCU, FPGA and sensor interface design experience.
• Power electronics for battery-powered devices incl. DC-DC.
• High-speed PCB design including Ethernet, USB, SPI, I2C, CAN.
• PCB design, DFM, DFT, SI/PI analysis.
• CAPA, NCR, change control and obsolescence management.
• Hardware verification and validation.
• Requirement traceability (RTM).
• Manufacturing transfer and sustaining engineering.
• Windchill / Agile PLM exposure.

Responsibilities

• Lead hardware design for regulated medical devices.
• Drive CAPA, change management and obsolescence mitigation.
• Perform schematic reviews, component selection, PCB reviews, and hardware validation.
• Execute risk assessments, V&V, compliance testing, and regulatory support.
• Support manufacturing transfers, supplier changes, and cost optimization programs.
• Collaborate with Systems, Firmware, Mechanical, Quality, Regulatory, and Manufacturing teams.

Skills

10+ years exp

Analog design

Digital design

Mixed-signal design

MCU

FPGA

Sensor interface

Power electronics

Battery devices

DC-DC converters

High-speed PCB

PCB design

DFM/DFT

SI/PI analysis

CAPA

NCR

Change control

Obsolescence mgmt

Hardware V&V

RTM

Manufacturing transfer

Windchill PLM

Tools

Windchill PLM

Job description

Senior Hardware Engineer – Medical Devices

Location: Tarrytown, NY, USA

Must-Have Skills

• 10+ years of experience
• 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
• Hardware Verification & Validation (V&V)
• Requirement Traceability (RTM)
• 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.