Senior Hardware Engineer – Medical Devices

Apex Bridge Talent Group; Village of Tarrytown (NY); On-site; USD 140,000 - 190,000; Full time

Job summary

Apex Bridge Talent Group is seeking a Senior Hardware Engineer for medical devices in the New York area. This on-site role focuses on hardware design, verification, and sustaining engineering for regulated devices.

You will lead analog/digital/mixed-signal design, PCB, power electronics, and contribute to regulatory compliance (IEC 60601-1, ISO 13485). Collaboration with Systems, Firmware, Quality, and Manufacturing teams is essential.

Qualifications

• 10+ years of experience in Medical Device Hardware Development.
• Analog, Digital & Mixed-Signal Design expertise including MCU/FPGA and sensor interfaces.
• Power electronics experience with battery-powered devices and DC-DC converters.
• High-speed PCB design involving Ethernet/USB/SPI/I2C/CAN.
• PCB design, DFM/DFT and signal integrity/physis analysis.
• CAPA, NCR, Change Control and obsolescence management.
• Hardware verification and validation activities (V&V).
• Requirement traceability (RTM) across lifecycle stages.
• Familiarity with IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 13485.
• FDA medical device regulations knowledge and manufacturing transfer experience.
• Manufacturing transfer and sustaining engineering responsibilities.
• Windchill/Agile PLM familiarity.

Responsibilities

• Lead hardware design, development, and sustaining engineering 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.

Skills

Medical Device Hardware Development

Analog, Digital & Mixed-Signal Design

MCU, FPGA, Sensor Interface Design

Power Electronics, Battery-Powered

High-Speed PCB Design

PCB Design, DFM, DFT, SI/PI

CAPA, NCR, Change Control & Obsolesc

Hardware Verification & Validation (V&

Requirement Traceability (RTM)

IEC 60601-1, IEC 60601-1-2, ISO 14971,

FDA Medical Device Regulations

Manufacturing Transfer & Sustaining

Windchill / Agile PLM

IVD / Clinical Diagnostics / Medical E

Cost Reduction, VAVE & Should-Cost

Safety & EMC Compliance Testing

Tools

Windchill / Agile PLM

Job description

Business Title: Senior Hardware Engineer – Medical Devices

Job Type: Direct hire (Contract is also an option.)

Work Setting: Onsite

Industry: Medical Device.

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.

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
• Hardware Verification & Validation (V&V)
• 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