Location: Irvine, CA (Onsite)

Overview:

Seeking a Design Quality Engineer to support product development activities by ensuring compliance with design control requirements, driving risk management, and supporting verification/validation efforts.

Required Experience:

• Bachelor’s degree in Engineering or related field
• 3+ years of experience in Design Quality or Design Assurance (medical device preferred)
• Strong knowledge of Design Controls, Risk Management (ISO 14971), and Verification/Validation
• Experience with product requirements, DHF documentation, and CAPA

Key Responsibilities:

• Support design and development teams to ensure product quality and regulatory compliance
• Lead Design Control activities and maintain DHF documentation
• Conduct risk management activities and update hazard analyses
• Review engineering requirements, test protocols, and reports
• Support V&V execution and address test non-conformances
• Collaborate cross-functionally to resolve quality issues and drive continuous improvement