100% Onsite

Job Summary

Ability to perform manual testing and analysis to identify defects, verify Software requirements and prepare documents based on QMS and regulatory environment, provide leadership to Software Test Engineers.

Essential Duties & Responsibilities

• Draft & execute Test Protocols
• Plan schedules for formal cycle testing
• Submit defects reports using defect tracking application and follow through on its resolution
• Prepare weekly test metrics and present report on a regular basis
• Participate in Defect Review Board and work with Software Quality Engineer to follow up on features & defects
• Review and update release of a digital record of a task, bug, or request used for tracking work in project management

Qualifications and Work Experience Required

• Bachelor's degree in Biomedical or Mechatronics or Computer Engineering, or a related field
• Perform manual testings on multiple projects
• Proficiency in Verification & Validation (V&V), Design Controls, Software Testing (SDLC), and Hardware Testing
• Deep understanding of FDA, ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management), IEC 62304 (Software Lifecycle), and EU MDR.
• Experience with test equipment (oscilloscopes, multimeters), diagnostic tools, CAD (SolidWorks), and scripting (Python, LabVIEW, MATLAB).
• Proficiency in written and spoken English
• Experience in drafting formal requirements
• Solid understanding Risk Assessment & Mitigation process
• 5+ years of software testing experience, role within the medical device or a regulated industry.