Job Title: Design Assurance EngineerLocation: Alameda, CAJob Summary:We are seeking a skilled and detail-oriented Design Assurance Engineer to support risk analysis, design verification, and quality system compliance for Class II/III medical devices. This role is critical in ensuring products meet regulatory and customer requirements throughout the product development lifecycle.Key Responsibilities:Lead and facilitate risk management activities including FMEA (Design and Process) in accordance with ISO 14971.Support design verification and validation activities, including test planning, protocol development, execution support, and report review.Ensure accurate and complete Design History File (DHF) and Device Master Record (DMR) documentation.Participate in design reviews and provide input on quality and compliance throughout product development.Ensure compliance with ISO 13485, FDA QSR, and other applicable regulatory standards.Drive root cause analysis and corrective/preventive actions (CAPA) for design-related quality issues.Collaborate with cross-functional teams including R&D, Regulatory, and Manufacturing.Qualifications:Bachelor’s degree in Engineering (Biomedical, Mechanical, or related field).3–6 years of experience in medical device design assurance or quality engineering.Strong knowledge of ISO 13485, 21 CFR Part 820, FMEA, DHF, and DMR.Experience with risk analysis and design verification activities.Familiarity with product development processes for regulated medical devices.Preferred Skills:Certification in Quality Engineering (CQE) or Risk Management (e.g., ISO 14971 training).Experience working with electromechanical or disposable medical devices.Proficiency in tools like MiniTab, DOORS, or similar quality documentation software.