Test Engineer – Medical Devices
1 week ago
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 (eg, 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:
- Bachelors or Masters 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)
- 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
Location: Delhi NCR,Bangalore,Chennai,Pune,Kolkata,Ahmedabad,Mumbai,Hyderabad
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