Job Description

Qualifications:

• Bachelor's or Master's in Engineering with 2+ years of relevant systems testing experience on complex capital equipment (Mechanical, Electrical, Software)
• Proven experience in medical device/medical equipment verification and validation. Familiar with ISO 13485, Design Control practices
• Familiar with electro-mechanical test equipment, including sensors, actuators, test automation, and data collection methods.
• Strong understanding of electro-mechanical systems and test equipment such as force gauge, calipers, Ingstron, Oscilloscopes, Coordinate Measurement Machines)
• Proficiency in design of experiments and statistical analysis.
• Ability to perform mechanical engineering calculations and use measurement tools.
• Excellent analytical, problem-solving, and communication skills.

Responsibilities:

• Develop and execute system-level test protocols and reports for medical devices.
• Conduct verification and validation testing, including regression and reliability tests.
• Analyze test data and perform root cause analysis of failures.
• Support product sustaining activities and design transfer processes.
• Manage test plans, timelines, and documentation.
• Collaborate with cross-functional teams to ensure product quality and compliance.

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