Software Test Engineer

BiVACOR Inc.; Gold Coast City; Presencial; AUD 75.000 - 85.000; Jornada completa

Descripción de la vacante

BiVACOR is seeking a Software Test Engineer to ensure safety and reliability of software behind our Total Artificial Heart, spanning embedded firmware, desktop, and web apps. You'll plan and run V&V activities, write test protocols, create automation, and contribute to regulatory submissions and quality systems, working closely with software, electrical, mechanical, and biomedical engineers.

This role emphasizes testing within IEC 62304, ISO 13485, FDA guidance, and Secure SDLC practices, with

Formación

• 2+ years in software testing or V&V, ideally in medical devices or regulated industry.
• Experience with embedded firmware, desktop and web apps testing.
• Knowledge of IEC 62304, ISO 13485, and FDA software guidance.

Responsabilidades

• Plan, design, and execute software V&V test protocols per IEC 62304 and 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 13485, IEC 62304, 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

Conocimientos

Software testing

V&V testing

Test automation

Python scripting

Documentation and writing

Attention to detail

Cross-disciplinary collaboration

Educación

Bachelor's degree in Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or related field

Herramientas

Python

Git / Version control

Descripción del empleo

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 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 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
• 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 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

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 opportunity 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.