Codvo.ai - Test Engineer - Black Box/White Box Testing

1 week ago

Pune, India Codvo.ai Full time

Job Description : Test Engineer Medical Devices & AI.

Experience Level :

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 :

- Bachelors or Masters degree in Engineering, Computer Science, Biomedical Engineering, or related field.

- 58 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.


(ref:hirist.tech)

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