At a Glance
- Tasks: Plan and execute software testing to ensure safety and reliability of innovative medical devices.
- Company: Join BiVACOR, a pioneering company developing a Total Artificial Heart.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and career advancement.
- Why this job: Make a real difference in patients' lives while working with cutting-edge technology.
- Qualifications: Bachelor's degree in relevant field and 2+ years of software testing experience.
The predicted salary is between 49500 - 60500 $ per year.
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 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
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
- Strong attention to detail and clear technical writing skills
- A collaborative 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 employer: BiVACOR Australia Pty Ltd
At BiVACOR, we pride ourselves on being an exceptional employer, offering a collaborative work culture where innovation meets purpose. As a Software Test Engineer, you'll not only contribute to groundbreaking medical technology but also enjoy opportunities for professional growth and development in a supportive environment. Located in a dynamic setting, our team is dedicated to making a meaningful impact on patients' lives, ensuring that your work is both rewarding and significant.
