Software Design Quality Assurance Engineer

Job Overview – Software Design Quality Assurance Engineer Atlantic Group is hiring a Software Design Quality Assurance Engineer in San Diego, CA for our client, supporting software quality, regulatory compliance, and design assurance within a medical device environment. This role focuses on ensuring compliance with standards such as IEC 62304 and FDA regulations across the software development lifecycle, including cloud-based and embedded systems. The position partners with cross-functional teams to support product development, risk management, and process improvement. Compensation: $130,000 – $150,000/year + bonus Location: San Diego, CA Schedule: Monday to Friday (Hybrid) Responsibilities as the Software Design Quality Assurance Engineer Design Assurance: Lead software quality activities across the development lifecycle to ensure compliance with regulatory standards. Regulatory Compliance: Ensure adherence to IEC 62304, FDA guidelines, and quality system requirements. Design Controls: Support development and review of design documentation including requirements, validation, and verification. Risk Management: Participate in software risk assessments and ensure alignment with applicable standards. Cross-Functional Collaboration: Partner with engineering, regulatory, and product teams to support development initiatives. Qualifications for the Software Design Quality Assurance Engineer Education: Bachelor’s degree in Computer Science, Engineering, or a related field required. Experience: 8+ years of experience in software quality engineering within a regulated environment. Certification: Relevant quality certifications such as ASQ or CSQE preferred. Industry Knowledge: Experience in medical device or biotechnology environments with knowledge of IEC 62304 required. Technical Skills: Experience with software development lifecycle, cloud-based systems, and quality tools. Skills & Attributes: Strong analytical, communication, and problem-solving skills in a fast-paced environment. #J-18808-Ljbffr Atlantic Group