Test Engineer – Medical Devices & AI (Remote)

India·PuneRemotemid

EngineeringQa Engineer

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Overview

Job Description: Test Engineer – Medical Devices & AI Experience Level: 5–8 Years Department: Product, Data and AI Engineering About the Role: We are seeking a highly skilled and detail-oriented Test Engineer with a strong background in medical technology (MedTech) and Artificial Intelligence (AI)…

Key Responsibilities

• Understand and evaluate the usage of AI/ML models in medical devices, including algorithm behavior, data integrity, and performance under various clinical scenarios.

Requirements Summary

• Bachelor’s or Master’s degree in Engineering, Computer Science, Biomedical Engineering, or related field. • 5–8 years of experience in software testing, preferably in medical devices or healthcare technology.

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Job Description: Test Engineer – Medical Devices & AI

Experience Level: 5–8 Years

Department: Product, Data and AI Engineering

About the Role:

We are seeking a highly skilled and detail-oriented Test Engineer with a strong background in medical technology (MedTech) and Artificial Intelligence (AI) to join our dynamic team. This role is critical in ensuring the safety, reliability, and compliance of AI-powered medical devices and Software as a Medical Device (SaMD) solutions.

Key Responsibilities:

• Understand and evaluate the usage of AI/ML models in medical devices, including algorithm behavior, data integrity, and performance under various clinical scenarios.

• Design and execute comprehensive white-box and black-box testing strategies for embedded systems, cloud-based platforms, and AI components.

• Apply knowledge of SaMD classification, regulatory frameworks (e.g., FDA, MDR), and quality processes to ensure product compliance and audit readiness.

• Lead 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-quality test plans, protocols, reports, and defect logs aligned with regulatory and internal standards.

• Work closely with product managers, data scientists, software engineers, and quality teams to ensure alignment and transparency throughout the development cycle.

• Clearly articulate test results, risks, and recommendations to technical and non-technical stakeholders.

Required Qualifications:

• Bachelor’s or Master’s degree in Engineering, Computer Science, Biomedical Engineering, or related field.

• 5–8 years of experience in software testing, 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.

• Experience with test automation tools and frameworks is a plus.

Preferred Skills:

• Knowledge of risk management processes (ISO 14971).