Engineer – AI Medical Devices at Jobgether – United States

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Systems Engineer – AI Medical Devices in United States.

This role focuses on the design, development, and validation of systems that support AI-driven medical devices. The Systems Engineer will ensure that Software as a Medical Device (SaMD) solutions meet regulatory requirements, safety standards, and performance expectations while enabling seamless integration across multidisciplinary teams. You will collaborate with software developers, ML scientists, clinical experts, and regulatory professionals to translate system requirements into scalable and reliable architectures. The role includes hands-on engineering, risk assessment, verification and validation, and documentation for compliance with FDA, ISO, and IEC standards. The ideal candidate thrives in a fast-paced, highly collaborative environment and is motivated by building systems that directly impact patient care and proactive healthcare. This position offers the opportunity to work at the intersection of AI, medical technology, and regulatory compliance while contributing to innovative healthcare solutions.

• Design, develop, and validate AI-enabled medical device systems, ensuring compliance with relevant regulations (e.g., FDA, ISO 13485, IEC 62304)
• Collaborate with cross-functional teams to integrate system requirements into software and hardware components
• Define system architecture, functional specifications, and risk management strategies
• Conduct risk assessments and manage mitigation activities related to system safety and performance
• Oversee verification and validation testing, ensuring traceability from requirements to system performance
• Support regulatory submissions, audits, and technical documentation for clearance of SaMD products
• Maintain system design control documentation, including requirements, design reviews, and traceability matrices

Requirements:

• 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 Software as a Medical Device (SaMD)
• 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
• Familiarity with software development lifecycle (SDLC) methodologies, Agile processes, and DevOps practices
• Experience with medical image processing, data security, and HIPAA/GDPR compliance is a plus
• Ability to implement automation in software development, including traceability, documentation generation, or CI/CD pipelines
• Excellent problem-solving skills, communication, and collaboration in a fast-paced, cross-functional environment

Benefits:

• Competitive hourly rate of $48-$58, depending on experience and location
• Opportunity to contribute to impactful healthcare solutions improving patient outcomes
• Work with cutting-edge AI and medical device technologies
• Collaborative and inclusive work environment valuing diversity and innovation
• Professional growth and learning opportunities in systems engineering and AI for healthcare
• Support for background checks and compliance with federal, state, and provincial rules