Medical Device Software Test Engineer – V&V & Automation

BiVACOR Australia Pty Ltd; Gold Coast City; Sur place; AUD 90 000 - 120 000; Plein temps

Résumé du poste

BiVACOR Australia Pty Ltd is seeking a Software Test Engineer to plan, execute, and document V&V testing across embedded firmware, desktop, and web applications. You will work closely with software, electrical, mechanical, and biomedical engineers to ensure safety, reliability, and regulatory readiness.

The role emphasizes test automation, scripting in Python, and contributing to the Secure Software Development Lifecycle, as well as supporting regulatory submissions and DHF documentation.

Qualifications

• Bachelor's degree in Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or a related field.
• 2+ years of experience in software testing or V&V, ideally in medical devices or another regulated industry.
• Working knowledge of IEC 62304, ISO 13485, and FDA software guidance.
• Experience testing embedded firmware and/or desktop and web applications.
• Experience with test automation and scripting (e.g., Python).
• Familiarity with version control and change management processes.
• Strong attention to detail and clear technical writing skills.
• A collaborative approach and comfort working across disciplines.

Responsabilités

• Plan, design, and execute software V&V test protocols in line with IEC 62304 and applicable FDA guidance.
• Write clear, traceable test protocols and scripts tied to system and software requirements.
• Document results and prepare V&V reports for regulatory submissions and the DHF
• Build, maintain, and improve automated test systems to increase coverage and efficiency.
• Identify and report software defects, test gaps, and quality risks to engineering and quality leads.
• Support unit and integration testing alongside software developers, and take part in design, code, and defect reviews.
• Contribute to cybersecurity activities as part of our Secure Software Development Lifecycle.
• Support system integration testing and resolve issues at the hardware-software interface.
• Support regulatory submissions (IDE, PMA, 510(k)), audit readiness, CAPA investigations, and software-related complaint handling.
• Maintain test plans, traceability matrices, and anomaly reports in line with ISO 13485, IEC 62304, GMP, and GDP

Connaissances

Test automation

Python scripting

Version control

Attention to detail

Technical writing

Cross-disciplinary collaboration

Formation

Bachelor's degree in Software Engineering / CS / EE / Biomedical Eng

Outils

Python

Git

Automation frameworks

Description du poste

BiVACOR Australia Pty Ltd is seeking a Software Test Engineer to plan, execute, and document V&V testing across embedded firmware, desktop, and web applications. You will work closely with software, electrical, mechanical, and biomedical engineers to ensure safety, reliability, and regulatory readiness.

The role emphasizes test automation, scripting in Python, and contributing to the Secure Software Development Lifecycle, as well as supporting regulatory submissions and DHF documentation.