Software Test Engineer

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

Education

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.