Medical Device Hardware Test Engineer

Position Summary

The Hardware/Product Safety Test Engineer is responsible for planning, developing, executing, and automating test strategies to verify and validate electronic hardware designs. This role works closely with hardware design, firmware, manufacturing, and quality teams to ensure products meet functional, performance, reliability, and regulatory requirements throughout the product lifecycle—from prototype through production release.

Key Responsibilities

· Develop and execute comprehensive test plans for electronic hardware, including PCB assemblies, subsystems, and complete products

· Design, build, and maintain hardware test setups, fixtures, and test equipment

· Perform functional, electrical, performance, stress, and environmental testing

· Debug and troubleshoot hardware failures at the component, board, and system levels

· Collaborate with hardware design engineers to review schematics, layouts, and design changes from a testability and reliability perspective

· Develop automated test scripts and tools to improve test coverage, repeatability, and efficiency

· Document test procedures, results, failure analysis, and corrective actions

· Support design verification (DVT), production validation (PVT), and manufacturing bring-up activities

· Assist with regulatory, safety, and compliance testing (e.g., EMC/EMI, ESD, thermal, safety)

· Provide feedback and recommendations to improve design robustness, manufacturability, and testability

Required Qualifications

· Bachelor’s degree in Electrical Engineering, Computer Engineering, or a related field

· 3 years of experience testing electronic hardware (experience level may be adjusted)

· Strong understanding of analog and digital circuits, power systems, and embedded hardware

· Proficiency with common lab equipment (oscilloscopes, logic analyzers, power supplies, signal generators, DMMs)

· Experience reading and interpreting schematics, PCB layouts, and datasheets

· Familiarity with 60601-1 standards and how standards differ from US to EU

· Product Safety Test Practical Experience - particularly 60601-1 compliance testing experience

· Familiarity with common test equipment used in 60601-1 compliance testing (AC Withstand Voltage Tester, HIPOT Tester, Electrical Safety Analyzer, Calipers, etc.)

· Hands-on experience with hardware debugging and root-cause analysis

· Strong technical documentation and communication skills

Preferred Qualifications

· Experience with test automation using Python, Shell/Command-line scripting, or similar tools

· Familiarity with embedded systems, firmware interaction, and communication protocols (I²C, SPI, UART, USB, Ethernet, etc.)

· Experience with manufacturing test development and production support

· Knowledge of reliability testing, environmental testing, and failure analysis methods

· Exposure to regulatory standards (FCC, CE, UL, IEC)