Test Engineer

Requirements

• Required Qualifications Education: Bachelor’s degree in Mechanical, Electrical, Biomedical, or Quality Engineering, or 3-4 additional years of trade experience Experience: 2–5 years of engineering experience within the medical device or regulated industry Regulations: Working knowledge of ISO 13485, FDA QSR, and ISO 14971 risk management standards Verification & Validation: Direct experience in planning and execution of Verification and Validation for complex electrotechnical devices Validation Skills: Direct experience writing and executing Equipment IQ/OQ/PQ and Test Method Validation (TMV) Technical Tools: Proficiency with data acquisition systems, and proficiency in analysis tools like MATLAB, or statistical software like Minitab Lab Skills: Hands-on experience using mechanical test equipment like tensile testers, gauges, and sensors Preferred Qualifications Experience with endoscopic surgical laser systems Experience with surgical fluid irrigation/aspiration systems and components (pumps, pressure sensors, flow sensors) Experience testing polymer-based fluid delivery components or single-use medical disposables (biocompatibility, sterilization validation) SolidWorks or CAD proficiency for mechanical fixture design Experience coding data acquisition using Python / C, able to troubleshoot basic code Able to read schematics Experience with rapid prototyping (SLA, FDM, CNC)
• Education: Bachelor’s degree in Mechanical, Electrical, Biomedical, or Quality Engineering, or 3-4 additional years of trade experience
• Experience: 2–5 years of engineering experience within the medical device or regulated industry
• Regulations: Working knowledge of ISO 13485, FDA QSR, and ISO 14971 risk management standards
• Verification & Validation: Direct experience in planning and execution of Verification and Validation for complex electrotechnical devices
• Validation Skills: Direct experience writing and executing Equipment IQ/OQ/PQ and Test Method Validation (TMV)