About the role

We're looking for a Software Test Engineer to help make sure the software behind our device is safe, reliable, and ready for regulatory review. You'll plan and run verification and validation (V&V;) testing across embedded firmware, desktop applications, and web applications, working closely with software, electrical, mechanical, and biomedical engineers. The role is focused on testing, and you'll also contribute across the wider software development lifecycle.

Key responsibilities
Plan, design, and execute software V&V; test protocols in line with IEC 62304 and applicable FDA guidance
Write explicit, traceable test protocols and scripts tied to system and software requirements
Document results and prepare V&V; reports for regulatory submissions and the Design History File (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

About you
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
Robust attention to detail and clear technical writing skills
A team-oriented approach and comfort working across disciplines

About us

BiVACOR is developing a Total Artificial Heart that uses magnetic levitation technology, built to give patients with end-stage heart failure a long-term alternative to waiting for a donor heart. Our team of engineers, clinicians, and scientists is working to bring this technology to the patients who need it most.

📌 Software Test Engineer Southport
🏢 BiVACOR Australia
📍 Southport