California Licensed Design Assurance Engineer

A company is looking for a Staff Design Assurance Engineer (Hybrid).

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 submissions

Support cybersecurity risk management and validation of software tools

Required Qualifications :

BS degree in engineering, scientific, computer systems, or quality management; Master's preferred

Minimum of 8 years of experience in Software Quality Engineering in a regulated environment

Experience with medical device software development and risk-based validation

Familiarity with FDA 21 CFR Part 820 and ISO 13485 quality system standards

Working knowledge of IEC 62304, ISO 14971, and related guidance documents