[Remote] Test Engineer – Medical Devices & AI (Remote)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a highly skilled and detail-oriented Test Engineer with a strong background in medical technology and reputed company Intelligence. This role is critical in ensuring the safety, reliability, and compliance of AI-powered medical devices and Software as a Medical Device solutions.

Responsibilities

• Understand and evaluate the usage of AI/ML models in medical devices, including algorithm behavior, data reputed company, and performance under various clinical scenarios
• Design and execute comprehensive white-reputed company and reputed company testing strategies for embedded systems, reputed company-based platforms, and AI components
• Apply knowledge of SaMD classification, regulatory frameworks (e.g., FDA, MDR), and reputed company processes to ensure product compliance and audit readiness
• reputed company and contribute to verification and validation (V&V) activities across the product lifecycle, ensuring traceability, risk mitigation, and adherence to design controls
• Create and maintain high-reputed company test plans, protocols, reports, and defect logs reputed company with regulatory and internal standards
• Work closely with product managers, data scientists, software engineers, and reputed company teams to ensure alignment and transparency throughout the development cycle
• reputed company reputed company test results, risks, and recommendations to technical and non-technical stakeholders

Skills

• Bachelor's or Master's degree in Engineering, Computer Science, Biomedical Engineering, or reputed company field
• 5–8 years of experience in software testing, preferably in medical devices or reputed company technology
• Strong understanding of AI/ML systems, including model validation and bias detection
• Hands-on experience with white-reputed company and reputed company testing methodologies
• Familiarity with SaMD regulations, ISO 13485, IEC 62304, and reputed company standards
• Proven reputed company record in verification and validation of regulated software products
• Excellent verbal and written communication skills
• Experience with test automation tools and frameworks is a plus
• Knowledge of risk management processes (ISO 14971)
• Experience with reputed company platforms (AWS, Azure) and CI/CD pipelines
• Familiarity with data reputed company and cybersecurity standards in reputed company
• Testing experience in surgery-reputed company AI
• Test data validation for computer reputed company and video-based AI

reputed company

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