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Codvo.ai - Test Engineer - Black Box/White Box Testing
4 weeks ago
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)
