Senior Staff Software Quality Engineer

A company is looking for a Staff Design Assurance Engineer (Remote/Flexible). Key Responsibilities Lead Design Control and Software Development initiatives for FDA Class II and Class III medical devices Ensure compliance with IEC 62304 and FDA Guidance on Software for 510(k) submissions Support cybersecurity risk management and validation of software tools Required Qualifications and Education BS degree in engineering, scientific, computer systems, or quality management; Master's degree preferred A minimum of 8 years of experience in Software Quality Engineering in regulated environments Experience with medical device software development and risk-based validation of software Working knowledge of FDA regulations, ISO 13485, and IEC 62304 Familiarity with software development tools and lifecycles

Apr 10, 2025 - 14:31

A company is looking for a Staff Design Assurance Engineer (Remote/Flexible). Key Responsibilities Lead Design Control and Software Development initiatives for FDA Class II and Class III medical devices Ensure compliance with IEC 62304 and FDA Guidance on Software for 510(k) submissions Support cybersecurity risk management and validation of software tools Required Qualifications and Education BS degree in engineering, scientific, computer systems, or quality management; Master's degree preferred A minimum of 8 years of experience in Software Quality Engineering in regulated environments Experience with medical device software development and risk-based validation of software Working knowledge of FDA regulations, ISO 13485, and IEC 62304 Familiarity with software development tools and lifecycles