Quality Engineer IV – Process Validation

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 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

• 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.

REQUIRED SKILLS & QUALIFICATIONS

• 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 (2023).
• Hands-on experience with software testing, threat modeling, SBOM tools, or vulnerability analysis.
• ISO 13485 auditor experience or training.

BiVACOR is a clinical stage medical device company developing the BiVACOR Total Artificial Heart (TAH), the first long-term therapy for patients with severe heart failure. The TAH is designed to replace the complete function of the native heart and address the global unmet need of patients with end-stage heart failure (HF) by providing a next generation life-extending solution.

Headquartered in Huntington Beach, CA and with an international office in Brisbane, Australia, BiVACOR was founded in 2008 by a team of internationally renowned biomedical engineers and cardiac surgeons, including Chief Technical Officer, Daniel Timms, PhD and Chief Medical Officer, William Cohn, MD. The original IP was developed by Daniel Timms who continues to collaborate with various researchers and institutes in Australia. Our highly driven and performing team has complementary science and business minds to focus on "Replacing Hearts and Restoring Lives."

Today, BiVACOR has a robust collaborative network that extends nationally and internationally and boasts a team of world-class engineers, medical specialists, and business executives fervent to advance this ground-breaking technology. Core to us and our culture is collaboration, working hard and recognizing those around us.

BiVACOR is an equal opportunity employer. We are committed to creating an inclusive environment for all employees. Our employment decisions are based on individual qualifications, job requirements and business needs without regard to race, color, marital status, sex, sexual orientation, gender identity and/or expression, age, religion, disability, citizenship status, national origin, pregnancy, veteran status and or any other legally protected characteristics. We are committed to providing reasonable accommodation, if you need an accommodation to complete the application process, please email hr@bivacor.com .

• Medical Benefits – Numerous HMO and PPO options, several of which have monthly premiums fully employer funded.
• Dental/Vision, Short-term & Long-term Disability also available at low employee cost.

BiVACOR also has very generous vacation and PTO policies. Vacation policy for first year employees is 80 hours per year. Increasing yearly up to 136 hours upon 7th year of employment. In addition to vacation, we also have a PTO policy equaling an additional 80 hours of time off per year.

BiVACOR proudly offers both Non-Elective and Elective 401(k) plans.

Our Non-Elective 401(k) is a 4% employer only contribution, made on your behalf each pay period and immediately vested upon 90-day qualification.

Our Elective 401(k)-employer match is up to 6%. That means that for every dollar you contribute to your 401 (k), you will receive a matching dollar-for-dollar contribution in your account up to 6% of your pay.

Short-Term and Long-Term Incentives are also part of our current benefit package.