Software QE

📋 Description

• Act as Software Quality representative for New Product Development and sustaining projects
• Provide oversight of Design Controls, SDLC compliance, software verification and validation
• Review and approve requirements, architecture, software design, risk management, cybersecurity
• Ensure compliance with IEC 62304, ISO 14971, ISO 13485, FDA QMSR, FDA Software Guidance, and
• Participate in software risk management, hazard analysis, and risk control verification activities.
• Support cybersecurity risk management in accordance with FDA guidance, AAMI TIR57/TIR97, and NIST

🎯 Requirements

• Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, Electrical
• 4+ years of Software Quality Engineering, Software Development, or Systems Engineering experience
• Hands-on experience with SaMD, Embedded Software, Connected Devices, or Robotics Software.
• Strong knowledge of IEC 62304, ISO 13485, ISO 14971, FDA Design Controls, FDA QMSR/QSR, and
• Experience with Agile methodologies and tools such as Jira or Azure DevOps.
• Understanding of Medical Device Cybersecurity, Secure SDLC, Threat Modeling, and Vulnerability

🎁 Benefits

• Equal Employment Opportunity Employer
• Fair chance laws consideration
• Potential for employment at different job level based on business need and candidate experience