Systems Engineer – AI Medical Devices (Contractor - USA)

Prenuvo is on a mission to transform healthcare through proactive solutions, offering a fast and safe whole body scan. They are seeking a Systems Engineer to support the design and development of AI-driven diagnostic tools while ensuring compliance with medical device regulations.

Responsibilities:

• 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

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 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
• 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
• 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
• Experience working with FDA and international regulatory bodies for medical device clearance
• Familiarity with AI/ML development in healthcare
• Understanding of medical device cybersecurity and risk management practices