Test Engineer – Medical Devices

19 hours ago

Pacific Remote Islands Marine National Monument, India Codvo Full time

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
  • 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.

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