Senior Verification & Validation Engineer - Process Transformation (AI)

TL;DR

Senior Verification & Validation Engineer (Process Transformation): Reimagining V&V processes in a regulated medical devices environment using AI and automation to transform workflows, reduce complexity, and enhance efficiency. Focus on integrating emerging technologies, piloting predictive testing, advancing data-driven risk detection, and ensuring regulatory compliance through innovative strategies.

Sydney, NSW, Australia (onsite, full-time)

Company

Global leader in medical devices for sleep apnea and respiratory care, committed to innovation and patient outcomes.

What you will do

• Drive process innovation by identifying, designing, and implementing initiatives to streamline V&V activities, reduce manual effort, and improve accuracy and compliance.
• Lead AI-driven transformation in verification and validation, including predictive testing, automation, and data-driven strategies.
• Scout, evaluate, and pilot emerging technologies to future-proof V&V capabilities and maintain innovation.
• Champion advanced automation and analytics for requirements traceability, risk assessment, and defect detection.
• Partner cross-functionally to integrate tools that enhance collaboration, system integration, and strategic decision-making using AI insights.
• Oversee creation and validation of V&V documentation for regulatory submissions and audits.

Requirements

• Bachelor’s degree in Engineering or Science.
• 5+ years in Verification & Validation, Systems Engineering, or related in regulated industry with technical leadership.
• Proven experience applying AI and automation to engineering workflows (predictive analytics, testing automation, data integration).
• Strong knowledge of requirements tools (DOORS, Jama, Jira) and data science environments (Python, MATLAB, Jupyter).
• Exceptional analytical and problem-solving skills for translating insights into strategic recommendations.

Nice to have

• Experience in medical devices or regulated industries.
• Contributions to AI in regulatory, quality, or compliance contexts (AI-assisted documentation, predictive risk management).

Culture & Benefits

• Culture of excellence, diversity, inclusion, and innovation.
• Supportive environment encouraging growth mindset and individual expression.
• Challenging career opportunities focused on meaningful impact and patient outcomes.