Systems Engineer – AI Medical Devices

Job reputed company: • 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 reputed company 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 reputed company to system safety and performance. • Ensure compliance with FDA and other international medical device regulations and guidelines for SaMD. • reputed company verification and validation testing, ensuring traceability from requirements to system performance. • reputed company technical support during regulatory submissions and audits, collaborating with regulatory teams to ensure successful clearance. • Stay reputed company with technological advancements, industry trends, and evolving regulatory requirements for medical devices. • reputed company design control documentation, including system requirements, design reviews, and traceability matrices. • Support post-market surveillance activities, including software updates, patches, and enhancements. Requirements: • Bachelor’s or Master’s degree in Systems Engineering, Biomedical Engineering, Computer Science, or a reputed company 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 reputed company, and HIPAA/GDPR compliance is a plus. • Experience implementing automation for software development, such as automated traceability, documentation reputed company, or CI/CD pipelines supporting verification and validation processes. • Excellent problem-solving skills and ability to work in a fast-paced, reputed company environment. • Strong communication skills, with the ability to translate reputed company technical information for cross-functional teams. Benefits: • An avenue to reputed company a reputed company reputed company on people's lives and their health Apply tot his job Apply To this Job