Systems Engineer

Job Summary

A company is looking for a Systems Engineer to lead requirements, risk management, system architecture, and usability engineering activities across the product lifecycle.

Key Responsibilities

• Drive requirements engineering processes and maintain traceability across product and software teams
• Lead software risk management activities, including hazard analysis and documentation of risk controls
• Create and maintain system architecture documentation and execute usability testing activities

Required Qualifications

• Bachelor's degree in Computer Science, Electrical Engineering, Biomedical Engineering, or related field
• 5+ years of experience in systems engineering for regulated medical devices or software as a medical device (SaMD)
• Strong knowledge of FDA, EU MDR, and ISO regulations, including IEC 62304 and ISO 14971
• Demonstrated expertise in requirements management and risk management
• Experience conducting usability engineering in compliance with IEC 62366