Codvo.ai · 3 months ago
Test Engineer – Medical Devices & AI (Remote)
United States
Full-time
Remote
Senior Level
5+ years expCodvo.ai is seeking a highly skilled and detail-oriented Test Engineer with a strong background in medical technology and Artificial Intelligence to join their dynamic team. This role is critical in ensuring the safety, reliability, and compliance of AI-powered medical devices and Software as a Medical Device solutions.
Information Technology
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
Qualification
Required
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
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
Company
Codvo.ai
At Codvo.ai, we specialize in leveraging artificial intelligence, cloud, and data to solve complex business problems and drive innovation.
51-200 employees
H1B Sponsorship
Codvo.ai has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2022 (3)
Funding
Current Stage
Growth StageLeadership Team
Amit Verma
Managing Partner
Harish Vajja
Managing Partner
Company data provided by crunchbase