Sr. Software Test Engineer

Job Title: Sr. Software Test Engineer

Job ID

37791392

Location

6101 West Courtyard Dr, Suite 1-225, USD3_Austin TX, 78730

Duration

06 Months

Job Description

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.

Skills

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.