Senior Medical Device Test Engineer – Onsite Austin

Lancesoft; Austin (TX); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Test protocol drafting

Cycle testing planning

Defect reporting

Test metrics reporting

Defect Review Board

Release documentation

Ausbildung

Bachelor's in Biomedical / Mechatronics / CE

Jobbeschreibung

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.