Test Engineer – Medical Devices & AI

Responsibilities

• Evaluate AI/ML models in medical devices, including algorithm behavior, data integrity, and clinical scenario performance
• Design and execute white-box and black-box testing strategies for embedded systems, cloud platforms, and AI components
• Apply SaMD classification and regulatory frameworks (FDA, MDR) to ensure compliance and audit readiness
• Lead verification and validation activities across the product lifecycle with full traceability and risk mitigation
• Create and maintain test plans, protocols, reports, and defect logs aligned with regulatory standards
• Collaborate with product managers, data scientists, engineers, and quality teams throughout development
• Communicate test results, risks, and recommendations to technical and non-technical stakeholders

Requirements

• 5–8 years of software testing experience, preferably in medical devices or healthcare technology
• Strong understanding of AI/ML systems, including model validation and bias detection
• Hands-on experience with white-box and black-box testing methodologies
• Familiarity with SaMD regulations, ISO 13485, IEC 62304, and related standards
• Proven track record in verification and validation of regulated software products
• Excellent verbal and written communication skills

Preferred Qualifications

• Knowledge of risk management processes (ISO 14971)
• Experience with cloud platforms (AWS, Azure) and CI/CD pipelines
• Familiarity with data privacy and cybersecurity standards in healthcare
• Testing experience in surgery-related AI
• Test data validation for computer vision and video-based AI

About the Company

codvo builds AI-powered medical devices and Software as a Medical Device (SaMD) solutions, combining expertise in MedTech, artificial intelligence, and regulatory compliance to deliver safe and reliable healthcare technology.