About BiVACOR

BiVACOR is a pioneering medical device company focused on developing the world’s first fully implantable, total artificial heart (TAH). Our team is driven by purpose — to transform the lives of patients with end-stage heart failure by delivering innovative, reliable, and life-saving cardiac technology. Join us as we continue advancing toward clinical use and commercialization.

Position Summary

We are seeking a Software Quality Engineer with strong cybersecurity experience to lead and support cybersecurity and software development compliance across our Total Artificial Heart system software and associated digital technologies. The ideal candidate will be passionate about patient safety, quality systems, and secure product design.

This position will spend approximately 80% of time supporting software and cybersecurity quality engineering activities globally and around 20% on broader quality assurance tasks including document control, CAPA, change control, supplier control and audit readiness.

This is a hybrid role based in our Gold Coast office. Candidates based in Brisbane are welcome to apply but must be willing to commute to the Gold Coast site multiple days per week or as required to support collaborative work and hands-on activities.

Key Responsibilities

Cybersecurity & Software Quality Engineering

Support secure software development lifecycle (SDLC) and risk management processes per IEC 81001-5-1, FDA Premarket Cybersecurity Guidance, and ISO 14971.

Review and approve software development documentation including threat modeling, architecture, verification protocols, configuration management, and software bills of materials (SBOM).

Collaborate with software and systems engineers to ensure secure-by-design product development.

Participate in vulnerability assessment, penetration testing, and third-party risk management activities.

Maintain cybersecurity risk assessments, controls, and traceability matrices.

Ensure design and process changes maintain cybersecurity posture across the device lifecycle.

Support audit and regulatory submissions related to software and cybersecurity compliance.

Quality Assurance

Participate in document control, training, and change control activities.

Support CAPA investigations and root cause analysis.

Assist with internal and external audits and inspection readiness.

Help ensure compliance to FDA QSR, ISO 13485, ISO 14971, and other applicable standards.

Support receiving and inspection of materials and components for quality conformance.

Assist with identifying and documenting nonconforming product and supporting investigations.

Contribute to supplier evaluations and support follow-up on quality-related issues.

Assist in managing quality records, design history files, and change control documentation.

Support process validation activities, facility controls, and ensure adherence to good documentation practices.

Key Qualifications

Required

Bachelor’s degree in software engineering, computer science, biomedical engineering, or related technical discipline.

Minimum 7 years of experience in software quality engineering, cybersecurity, or a regulated software development environment.

Strong working knowledge of IEC 62304, ISO 14971, and current FDA and international cybersecurity guidance.

Familiarity with cybersecurity risk management frameworks (e.g., NIST, ISO 27001).

Experience reviewing technical documentation for medical or safety-critical software.

Excellent written and verbal communication skills.

Preferred

Experience in Class III medical devices or implantable systems.

Familiarity with IEC 81001-5-1, UL 2900, or FDA Premarket Cybersecurity Final Guidance (2023).

Hands-on experience with software testing, threat modeling, SBOM tools, or vulnerability analysis.

ISO 13485 auditor experience or training.

What We Offer

The opportunity to contribute to a life-saving technology at the forefront of medical innovation.

A collaborative, mission-driven team in a fast-paced startup environment.

Hybrid work flexibility with the expectation of regular in-office collaboration.