Senior Hardware Engineer - Medical Devices

Job Title: Senior Hardware Engineer – Medical Devices

Location: Tarrytown, NY, USA

Positions: 1

Experience: 10–15 Years

Work Authorization: USC, Green Card, H-1B

Work Arrangement: To be confirmed

Job Summary

We are seeking an experienced Senior Hardware Engineer with 10–15 years of hands-on experience in medical device hardware development, electronics design, and product engineering. The ideal candidate will have strong expertise in analog, digital, and mixed-signal circuit design, PCB development, embedded hardware interfaces, power electronics, and hardware verification and validation.

The candidate will be responsible for leading hardware design and development activities for regulated medical devices, ensuring product safety, reliability, performance, and compliance with applicable medical device standards. Experience with medical equipment, in-vitro diagnostic (IVD) systems, risk management, and regulatory compliance is highly desirable.

Key Responsibilities

• Lead hardware design, development, testing, and sustaining engineering activities for regulated medical devices.
• Design and review analog, digital, and mixed-signal electronic circuits.
• Perform schematic design, component selection, PCB design reviews, and hardware architecture evaluations.
• Develop hardware interfaces for microcontrollers (MCUs), FPGAs, sensors, and other electronic components.
• Design and support battery-powered systems, power electronics, power management circuits, and DC-DC converters.
• Implement and evaluate high-speed communication interfaces, including USB, Ethernet, SPI, I2C, CAN, and RS232.
• Apply signal integrity (SI), power integrity (PI), design for manufacturing (DFM), and design for testability (DFT) principles.
• Execute hardware verification and validation (V&V), troubleshooting, failure analysis, and performance testing.
• Conduct hardware risk assessments and support risk management activities in accordance with ISO 14971.
• Support compliance testing and product development activities related to IEC 60601-1, IEC 60601-1-2, and ISO 13485.
• Maintain hardware design documentation, engineering change records, and product lifecycle information using Windchill or Agile PLM.
• Support manufacturing transfers, supplier changes, component obsolescence management, and cost optimization initiatives.
• Collaborate with Systems Engineering, Firmware, Mechanical Engineering, Quality, Regulatory, and Manufacturing teams.
• Provide technical guidance during design reviews, product troubleshooting, and continuous improvement initiatives.

Required Qualifications and Skills

• 10–15 years of experience in hardware development, preferably focused on medical devices or regulated medical equipment.
• Strong hands-on experience in analog, digital, and mixed-signal circuit design.
• Experience with PCB design, schematic capture, PCB layout reviews, and component selection.
• Knowledge of signal integrity, power integrity, and high-speed PCB design constraints.
• Experience with microcontrollers, FPGAs, sensor interfaces, and embedded hardware integration.
• Strong understanding of power electronics, battery-powered devices, and DC-DC converters.
• Experience with communication interfaces such as USB, I2C, SPI, RS232, Ethernet, CAN, GSM, and Bluetooth.
• Experience with hardware verification, validation, testing, and troubleshooting.
• Hands-on experience with hardware risk management and failure analysis.
• Familiarity with medical device standards, including IEC 60601-1, IEC 60601-1-2, ISO 14971, and ISO 13485.
• Proficiency with PCB design tools such as Altium Designer and/or OrCAD.
• Experience with product lifecycle management (PLM) tools such as Windchill or Agile PLM.
• Strong analytical, problem-solving, documentation, and cross-functional collaboration skills.

Preferred Qualifications

• Prior experience designing medical equipment, diagnostic instruments, or in-vitro diagnostic (IVD) systems.
• Experience with motion control systems, motor drivers, and precision sensors.
• Experience supporting regulatory submissions, EMC testing, manufacturing transfers, and product sustaining activities.
• Experience with design for manufacturing, design for testability, and hardware cost optimization.

Ideal Candidate Profile

The ideal candidate is a hands-on senior hardware engineer with a strong background in medical device electronics, PCB design, embedded hardware interfaces, and regulated product development. The candidate should be capable of independently driving hardware engineering activities from design through verification, validation, compliance, and manufacturing support.