Job Overview – Design Quality Engineer (Medical Devices)
Compensation: $130,000 – $155,000/year + bonus
Location: San Diego, CA
Schedule: Monday to Friday (Hybrid)
Atlantic Group is hiring a Design Quality Engineer (Medical Devices) in San Diego, CA for our client, supporting software quality, design assurance, and regulatory compliance across medical device systems. This role focuses on end-to-end software quality across device functionality, ensuring compliance with IEC 62304 and FDA standards throughout the software development lifecycle. The position partners closely with engineering and cross-functional teams to support product development, risk management, and process improvement.
Responsibilities as the Design Quality Engineer (Medical Devices):
- Design Assurance: Lead software quality activities across the development lifecycle to ensure compliant product development.
- Regulatory Compliance: Ensure adherence to IEC 62304, FDA requirements, and quality system standards.
- Design Controls: Guide development and review of software design documentation including requirements, validation, and verification.
- Risk Management: Support software risk assessments in alignment with ISO 14971 and related standards.
- Technical Review: Review specifications, test plans, and validation documentation to ensure quality and completeness.
- Process Improvement: Enhance quality systems, controls, and documentation to support scalable development.
Qualifications for the Design Quality Engineer (Medical Devices):
- Education: Bachelor’s degree in Engineering, Computer Science, or a related field required. ASQ, CSQE, or similar certification preferred.
- Experience: 8+ years of experience in software quality engineering within a regulated environment.
- Industry Knowledge: Experience in medical device software with strong knowledge of IEC 62304 required.
- Technical Skills: Experience with software development lifecycle, design controls, and quality systems.
- Skills & Attributes: Strong analytical, communication, and problem-solving skills in a fast-paced environment.
Application Notice: Qualified candidates will be contacted within 2 business days of application. If an applicant does not meet the above criteria, Atlantic Group will keep your resume on file for future opportunities and may contact you for further discussion.