Systems Engineer

Systems Engineer

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.

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.

Preferred Qualifications

• 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.