Hardware Test Lead - Ultrasound

17 Minutes ago • 8 Years +

Testing

Job Description

The Hardware Test Lead is a pivotal role responsible for leading, planning, and executing Design Qualification Tests (DQT) for Ultrasound products, ensuring compliance with performance, safety, and regulatory standards. This position oversees hardware module testing, develops robust test methodologies, and manages the hardware test laboratory to maintain a safe, organized, and efficient testing environment. The Hardware Test Lead collaborates with engineering teams, project managers, and quality assurance to deliver reliable, high-quality hardware solutions through rigorous verification processes.

Good To Have:

Medical electronics experience.

Must Have:

Develop and implement DQT strategies for all projects, ensuring alignment with project goals, timelines.
Lead testing activities, including L4L Type Test, Safety Testing, EMC Testing, Environmental Testing.
Oversee Reliability Testing and plan/execute Component Lifetime Tests, Accelerated Life Testing, and Real-Time Aging Tests.
Develop and implement Test Methodologies (MSA) to ensure measurement accuracy and consistency.
Lead the build-up of Test Benches and Jigs, designing and assembling custom test fixtures.
Execute module-level verification, including functional and performance, and manage defects.
Oversee Environmental, Health, and Safety (EHS) compliance in the test lab.
Implement and maintain 5S practices for an organized, efficient, and clean lab environment.
Manage Test Instruments, including calibration, maintenance, and procurement.
Bachelor’s or Master’s degree in Electrical Engineering, Electronics, Mechanical Engineering, or a related field.
8+ years of experience in hardware testing, with at least 3 years in a leadership role.
Strong knowledge of medical device standards and testing methodologies for safety, EMC, and environmental compliance.
Expertise in reliability engineering, statistical analysis (e.g., Weibull, Minitab), and test automation tools.
Experience in designing and building test benches, jigs, and automated test systems.
Proficiency in lab management practices, including EHS compliance and 5S implementation.
Excellent project management, problem-solving, and communication skills.

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Job Title

Hardware Test Lead - Ultrasound

Job Description

Your role:

Leadership and Planning of Design Qualification Tests (DQT):

Develop and implement DQT strategies for all projects, ensuring alignment with project goals, timelines.
Lead testing activities, including:
L4L Type Test, including Safety Testing, EMC Testing, Environmental Testing to support NMPA registration.
Oversee Reliability Testing to assess product durability and performance under operational stresses.
Plan and execute Component Lifetime Tests, Accelerated Life Testing as well as Real-Time Aging Tests to provide evidence of expected service life for NMPA registration.
Coordinate resources, schedules, and budgets for DQT activities, providing clear documentation and risk assessments to stakeholders.

Hardware Module/Component Verification:

Develop and implement Test Methodologies (MSA - Measurement System Analysis): Create standardized, repeatable test protocols, including gauge R&R studies, to ensure measurement accuracy and consistency.
Lead the build-up of Test Benches and Jigs: Design, procure, and assemble custom test fixtures, automated test benches, and tooling to support efficient and precise verification of hardware modules and components.
Execute module-level verification, including functional, performance.
Manage defects found during test or verification.

Hardware Test Lab Management:

Oversee Environmental, Health, and Safety (EHS) compliance in the test lab, ensuring adherence to workplace safety regulations and protocols.
Implement and maintain 5S (Sort, Set in Order, Shine, Standardize, Sustain) practices to ensure an organized, efficient, and clean lab environment.
Manage Test Instruments: Oversee the calibration, maintenance, and procurement of test equipment to ensure accuracy and availability for testing activities.
Monitor lab operations, standardize workflows, and ensure proper documentation of test procedures and results.

You're the right fit if:

Bachelor’s or Master’s degree in Electrical Engineering, Electronics, Mechanical Engineering, or a related field.
8+ years of experience in hardware testing, with at least 3 years in a leadership role overseeing DQT or similar qualification processes.
Strong knowledge of medical device standards and testing methodologies for safety, EMC, and environmental compliance.
Expertise in reliability engineering, statistical analysis (e.g., Weibull, Minitab), and test automation tools.
Experience in designing and building test benches, jigs, and automated test systems.
Proficiency in lab management practices, including EHS compliance and 5S implementation.
Excellent project management, problem-solving, and communication skills to collaborate with cross-functional teams and present technical findings.
Excellent writing and verbal communication skills
A team player who proactively seeks expertise and advice from others.

Preferred:

Medical electronics experience

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