Software Test Engineer

LanceSoft, Inc.; Austin (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Lancesoft in Austin, TX is seeking an experienced Software Test Engineer to perform manual testing and lead a team in a regulated medical-device environment. The role requires verifying software requirements, preparing QA documentation, and ensuring compliance with QMS standards.

Responsibilities include defect reporting, weekly metrics, and collaboration with the Quality Engineer to address features and defects. Strong English communication and familiarity with FDA ISO standards are essential.

Qualifications

• Bachelor's degree in Biomedical, Mechatronics or Computer Engineering; related field.
• Manual testing across multiple projects.
• Knowledge of V&V, Design Controls, SDLC and Hardware Testing.
• Familiarity with FDA ISO 13485/14971 and IEC 62304.
• Experience with test equipment, CAD tools and scripting (Python, LabVIEW, MATLAB).
• Proficient in written and spoken English.

Responsibilities

• Perform manual testing to identify defects and verify software requirements.
• Prepare and maintain documents per QMS and regulatory environment.
• Provide leadership to Software Test Engineers.
• Submit defect reports and track resolutions.
• Prepare weekly test metrics and present reports.
• Collaborate with Quality Engineer to follow up on features and defects.
• Review and update release notes for digital task/defect tracking in PM tools.

Skills

Test protocol drafting

Cycle testing planning

Defect reporting

Test metrics reporting

Defect Review Board

Release documentation

Education

Bachelor's in Biomedical / Mechatronics / CE

Job description

Location: Austin, TX – 78730 - 100% Onsite

Duration: 5 Months (end date is 04/30/2027)

Duties

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

• 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

5+ years of software testing experience, role within the medical device or a regulated industry.