A company is looking for a Staff Design Assurance Engineer (Hybrid).
Key Responsibilities
Lead Design Control and Software Development initiatives for medical devices and related systems
Ensure compliance with IEC 62304 and FDA Guidance on software 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 preferred
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 and ISO standards related to quality systems
Familiarity with software development tools and lifecycles emphasizing quality engineering
Software Qa Engineer • Lexington, Kentucky, United States