Support the design, development, and validation of Software as a Medical Device (SaMD) solutions, ensuring compliance with relevant medical device regulations and standards (e.g., ISO 13485, IEC 62304).
Collaborate with cross-functional teams, including ML scientists, software developers, clinical experts, regulatory affairs, and quality assurance, to ensure seamless integration of system requirements.
Coordinate and document the development of system architecture that ensures scalability, reliability, and compliance with safety and performance standards.
Define and document system requirements, functional specifications, risk management strategies, and validation procedures.
Conduct risk assessments and manage risk mitigation activities related to system safety and performance.
Ensure compliance with FDA and other international medical device regulations and guidelines for SaMD.
Oversee verification and validation testing, ensuring traceability from requirements to system performance.
Provide technical support during regulatory submissions and audits, collaborating with regulatory teams to ensure successful clearance.
Stay current with technological advancements, industry trends, and evolving regulatory requirements for medical devices.
Develop design control documentation, including system requirements, design reviews, and traceability matrices.
Support post-market surveillance activities, including software updates, patches, and enhancements.

Bachelor’s or Master’s degree in Systems Engineering, Biomedical Engineering, Computer Science, or a related field.
Proven experience in system engineering for medical device development, specifically for SaMD.
Must have strong knowledge of regulatory standards and frameworks for medical devices (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
Proficiency in system architecture design, risk management, and validation processes for SaMD.
Familiarity with software development lifecycle (SDLC) methodologies, Agile processes, and DevOps.
Experience with medical image processing, data security, and HIPAA/GDPR compliance is a plus.
Experience implementing automation for software development, such as automated traceability, documentation generation, or CI/CD pipelines supporting verification and validation processes.
Excellent problem-solving skills and ability to work in a fast-paced, collaborative environment.
Strong communication skills, with the ability to translate complex technical information for cross-functional teams.

Systems Engineer – AI Medical Devices

Key skills