Job Title: Cybersecurity Engineer – Software Validation
We are seeking a highly skilled Cybersecurity Engineer 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 is a hybrid role based in our office. Candidates welcome to apply from Brisbane may need to commute to the Gold Coast site multiple days per week or as required.
Cybersecurity & Software Quality Engineering Responsibilities:
* Support secure software development lifecycle (SDLC) and risk management processes per international standards.
* 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 that design and process changes maintain a robust cybersecurity posture throughout the device lifecycle.
* Support audit and regulatory submissions related to software and cybersecurity compliance.
Quality Assurance Responsibilities:
* 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 with FDA regulations, ISO standards, and other applicable standards.
* Support the receiving and inspection of materials and components for quality conformance.
* Assist with identifying and documenting nonconforming products 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.
Requirements:
* 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 international cybersecurity guidance and standards.
* Familiarity with cybersecurity risk management frameworks (e.g., NIST, ISO).
* Experience reviewing technical documentation for medical or safety-critical software.
* Excellent written and verbal communication skills.
Preferred Qualifications:
* Experience in Class III medical devices or implantable systems.
* Familiarity with relevant industry standards and guidelines.
* Hands-on experience with software testing, threat modeling, SBOM tools, or vulnerability analysis.
* ISO auditor experience or training.