Lead Medical Device Hardware Engineer (Regulated Systems)

Apetan Consulting LLC; New York (NY); On-site; USD 140,000 - 210,000; Full time

Job summary

Apetan Consulting LLC seeks a Senior Hardware Engineer for medical devices in New York, NY. You will lead hardware development for regulated devices, conduct schematic reviews, and drive hardware validation in collaboration with Systems, Firmware, and Quality teams.

Ideal candidates have 10–15 years in medical device hardware, strong analog, mixed-signal, high‑speed PCB experience, and hands-on risk management. Regulatory standards expertise (IEC 60601, ISO 14971) is essential.

Qualifications

• 10-15 years in medical device hardware development.
• Expert in analog, digital and mixed-signal design.
• Experience with signal integrity and layout constraints.
• Proficient MCU/FPGA and sensor interface design.
• Power electronics for battery-powered devices and DC-DC converters.
• High-speed PCB design including Ethernet, USB, SPI, I2C, CAN.
• PCB design, DFM/DFT, SI/PI analysis.
• Hardware verification and validation.
• Hands-on risk management and IEC/ISO regulatory standards.
• Windchill / Agile PLM experience.
• Interfaces: USB, I2C, SPI, RS232, Ethernet, GSM, Bluetooth; ECAD tools Altium/OrCAD

Responsibilities

• Lead hardware design, development and sustaining engineering for regulated medical devices.
• Perform schematic reviews, component selection and PCB design reviews.
• Execute risk assessments, V&V, compliance testing and regulatory support.
• Support manufacturing transfers, supplier changes and cost optimization.
• Collaborate with Systems, Firmware, Mechanical, Quality, Regulatory and Manufacturing teams.

Skills

Medical device hardware

Analog & digital design

Signal integrity

MCU design

FPGA design

Power electronics

Battery-powered devices

High-speed PCB

PCB layout

DFM/DFT

Hardware V&V

Risk management

IEC 60601

ISO 14971/ISO 13485

Windchill/Agile PLM

Tools

Altium

OrCAD

Job description

Apetan Consulting LLC seeks a Senior Hardware Engineer for medical devices in New York, NY. You will lead hardware development for regulated devices, conduct schematic reviews, and drive hardware validation in collaboration with Systems, Firmware, and Quality teams.

Ideal candidates have 10–15 years in medical device hardware, strong analog, mixed-signal, high‑speed PCB experience, and hands-on risk management. Regulatory standards expertise (IEC 60601, ISO 14971) is essential.