Risk management and V&V Engineer

In this role, you will lead risk management for AI-enabled SaMD in imaging, ensuring compliance with medical device standards. You will define verification and validation strategies and align with cross-functional teams to deliver safe, regulatory-compliant products. You’ll address AI-specific risks like performance, bias, cybersecurity, and drift, supporting regulatory submissions and post-market activities. This is a chance to shape risk governance in a diverse, values-driven culture that tackles challenging engineering problems.

• Lead risk management activities for AI SaMD products in compliance with ISO 14971
• Define and oversee verification and validation strategies for AI/ML-based medical software
• Ensure compliance with IEC 62304, ISO 13485, FDA SaMD guidance, EU MDR, and GMLP
• Evaluate AI-specific risks including model performance, bias, cybersecurity, data integrity, and model drift
• Support regulatory submissions, audits, and post-market surveillance
• Collaborate with Engineering, Data Science, Clinical, Quality, and Regulatory teams for safe product releases

• 8+ years in Medical Device Software, Quality, Validation, or Regulatory Compliance
• 3+ years in AI/ML-enabled healthcare solutions focused on CT/MRI/US imaging
• AI/ML Risk Management
• Software Verification & Validation (V&V)
• Medical Device Regulatory Compliance
• Requirements Traceability
• Cybersecurity & Quality Management Systems
• Stakeholder Management and Cross-functional Leadership

• Stakeholder management
• Cross-functional collaboration
• Leadership
• AI/ML Risk Management
• Software Verification & Validation (V&V)
• Medical Device Regulatory Compliance