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.
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.
What You'll Do
Plan, design, and execute software V&V; test protocols in line with IEC ***** 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 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 *****, IEC *****, GMP, and GDP
Provide test support for manufacturing test equipment, production fixtures, and device acceptance testing
Suggest improvements to test efficiency, automation coverage, and development practices
What You'll Bring
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 *****, ISO *****, 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
Compensation
The base salary range for this role is $75,000 - $85,000 AUD. The final offer will depend on experience and qualifications.
BiVACOR is an equal chance employer. We welcome applicants of all backgrounds and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected characteristic.
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📌 Software Test Engineer (Gold Coast)
🏢 Bivacor
📍 Gold Coast