Description

You will support the design, development, and validation of AI-driven SaMD solutions, ensuring compliance with medical device regulations like ISO 13485 and IEC 62304. Collaborate with cross-functional teams to integrate system requirements, conduct risk assessments, and oversee verification and validation testing. This role offers the opportunity to work with cutting-edge technology and contribute to proactive healthcare.

Requirements

• Bachelor's/Master's in Systems Engineering, Biomedical Engineering, Computer Science, or related field
• Proven experience in system engineering for medical device development, specifically SaMD
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304
• Proficiency in system architecture design, risk management, and validation for SaMD
• Familiarity with SDLC, Agile, DevOps

Responsibilities

• Support design, development, and validation of SaMD solutions
• Collaborate with ML scientists, developers, clinical, regulatory, and QA teams
• Define system requirements, functional specs, risk management, and validation procedures
• Conduct risk assessments and manage mitigation activities
• Oversee verification and validation testing with traceability