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The Hardware Test Engineer is responsible for designing hardware test procedures and testing mechanical, electrical and electronic designs to support the Company’s Quality System. The Hardware Test Engineer acts as the subject matter expert on all testing prior to design implementation for manufacturing. They are responsible for sustaining and upgrading test design to ensure Quality standards are being met.
Job Responsibility:
Perform hardware testing activities, including (re)design, debugging, modification, and verification of hardware components for company products
Develop, update, and execute test procedures, including component and system-level verification testing, and prepare verification plans and reports
Report defects in the defect tracking system and verify corrective fixes
Develop manufacturing and test instructions and support manufacturing activities as needed
Transfer designs to in-house or contract manufacturing and act as liaison with contract manufacturers to resolve design issues identified during testing
Participate in and occasionally lead design reviews, providing expertise in hardware design and testing
Contribute to system requirements and specifications for device development
Ensure all design work complies with Profound Medical’s Design Control Procedures and applicable regulatory standards
Ensure electrical safety, support risk management and usability engineering activities, and participate in device safety assessments
Work with certification laboratories to test and certify products to applicable safety and EMC standards and ensure compliance with environmental regulations (RoHS)
Investigate product complaints, perform root cause analysis of failures, and implement corrective actions in a timely manner
Lead hardware improvement projects as required by business needs
Travel (20–50%) to support testing, certification, manufacturing, and other business activities
Requirements:
University degree in Electrical/ Biomedical Engineering
2–3+ years of experience in hardware testing within the medical device industry or other regulated environments
Strong knowledge of test engineering principles for analog, digital, and RF mixed-signal designs
Experience with electrical/RF engineering for MRI-compatible devices is an asset
Familiarity with the IEC 60601 family of standards and regulatory requirements for medical devices
Experience in EMC design and testing
Solid understanding of MRI physics
Demonstrated ability to design, test, and deliver high-quality products within defined timelines
Strong analytical and creative problem-solving skills with attention to detail
Excellent written and verbal technical communication skills
Ability to work effectively both independently and within cross-functional teams
Valid driver's license and passport
ability to travel internationally (U.S. and Europe) on short notice
Nice to have:
Experience with electrical/RF engineering for MRI-compatible devices