Senior Hardware Engineer Medical Devices PCB

Accord Technologies Inc; Village of Tarrytown (NY); On-site; USD 150,000 - 210,000; Full time

Job summary

Accord Technologies Inc. is seeking a Senior Hardware Engineer for medical devices in Tarrytown, NY. You will lead hardware design, drive CAPA and obsolescence mitigation, and coordinate with cross-functional teams to ensure compliance and on-time delivery.

10+ years in medical device hardware, analog/digital/mixed-signal design, and experience with ISO 13485 and FDA regulations are required. On-site role with opportunities for product lifecycle impact.

Qualifications

• 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, 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 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

Hardware design

Analog, digital & mixed-signal

MCU/FPGA

Power electronics

High-speed PCB design

DFM/DFT/SI-PI

CAPA/NC/obsolescence

RTM

V&V & regulatory

Risk management (FMEA)

Windchill/PLM

Tools

Windchill / Agile PLM

Job description

Senior Hardware Engineer Medical Devices

Location: Tarrytown, NY, USA

Positions: 1

Visa: USC/GC/H1B

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.