Secure Product Designer

We are seeking an experienced Software Quality 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 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.

Cybersecurity & Software Quality Engineering Responsibilities:

• 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 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 QSR, ISO 13485, ISO 14971, 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 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 Qualifications:

• Experience in Class III medical devices or implantable systems.
• Familiarity with IEC 81001-5-1, UL 2900, or FDA Premarket Cybersecurity Final Guidance.
• Hands-on experience with software testing, threat modeling, SBOM tools, or vulnerability analysis.
• ISO 13485 auditor experience or training.

About Us

We are a clinical stage medical device company developing a groundbreaking technology to address the global unmet need of patients with end-stage heart failure.

Our team of world-class engineers, medical specialists, and business executives is dedicated to advancing this life-changing solution.

We are committed to creating an inclusive environment for all employees and fostering a culture of collaboration and innovation.

Benefits

We offer a comprehensive benefits package, including medical, dental, and vision coverage, short-term and long-term disability insurance, and a 401(k) plan.

Additionally, we provide generous vacation and PTO policies, incentives, and opportunities for professional growth and development.

Why Work With Us?

Join a dynamic and innovative team driven by a passion for improving patient outcomes and advancing medical technology.

Enjoy a collaborative and inclusive work environment, competitive compensation and benefits, and opportunities for career advancement.