We're Hiring! AI Engineer – AI-Enabled Software as a Medical Device (SaMD)

Are you passionate about AI in healthcare? We are looking for an experienced AI Engineer to join our team and lead the design, development, verification, validation, and maintenance of AI-based Software as a Medical Device (SaMD). As part of this role, you’ll work with cross-functional teams across geographies and cultures, ensuring compliance with industry standards and regulatory guidelines. 🌟 Key Responsibilities: Develop and maintain AI software in compliance with EN 62304 and ISO 13485. Implement risk management processes in line with ISO 14971. Ensure regulatory compliance through documentation for traceability, design controls, and V&V activities. Apply ISO 42001, AI governance frameworks, and GMLP principles to drive the development of AI-based medical devices. Implement robust data management systems to ensure data integrity, security, and traceability. 📩 Apply Now to sonali.tomar@saracasolutions.com. or share this with someone who might be interested!

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