Medical Device Software Test Engineer - V&V & Automation

BiVACOR Inc.; Gold Coast City; On-site; AUD 75,000 - 85,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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

Skills

Software testing

V&V testing

Test automation

Python scripting

Documentation and writing

Attention to detail

Cross-disciplinary collaboration

Education

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

Tools

Python

Git / Version control

Job description

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