Software Quality Test Engineer

About the role

As a Software Quality Test Engineer on Akura Medical’s quality team, you will own software quality activities across the product lifecycle for the thrombectomy platform. You will develop test cases, maintain requirements traceability, and execute verification testing while ensuring compliance with FDA Quality System Regulations, ISO 13485, ISO 14971, and IEC 62304.

Key responsibilities

• Develop, review, and maintain software test cases derived from approved requirements and design specifications.
• Assist in implementing automated testing software and execute non‑product software validation.
• Create and maintain the Software Requirements Traceability Matrix linking user needs, requirements, design, risk controls, test cases, and results.
• Execute verification, integration, and regression testing, capturing objective evidence and recording results in the test management system.
• Author test protocols, reports, and summary documents that meet IEC 62304 and design control expectations.
• Identify, document, and track software anomalies to closure, participating in root‑cause analysis and retesting.
• Support software risk management activities, including review of software FMEA and traceability of risk controls.
• Contribute to the software portion of the Design and Development File and support change control assessments.

Required profile

• Experience developing and maintaining software test cases and executing verification testing.
• Ability to work closely with software, systems, and R&D engineering teams.
• Familiarity with FDA QSR, ISO 13485, ISO 14971, and IEC 62304 regulatory requirements.
• Strong documentation skills for test protocols, reports, and traceability matrices.
• Proven ability to track defects, perform root‑cause analysis, and verify fixes.

Required skills

• Software test case development
• Requirements traceability matrix creation
• Test management system usage
• Automated testing tool implementation
• Software verification, integration and regression testing
• Root‑cause analysis and defect tracking
• Software risk management (ISO 14971)
• Knowledge of FDA QSR, ISO 13485, IEC 62304