Massachusetts Licensed Software QA Engineer

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