Design Quality Engineer - Software Remediation

We are seeking a Design Quality Engineer to support software and design remediation within a regulated medical device environment. This role focuses on evaluating end-to-end design quality, identifying gaps in design controls and documentation, and driving sustainable corrective actions. The ideal candidate will connect risk management, design inputs and outputs, requirements, implementation, verification and validation, traceability, and the Design History File (DHF) to ensure a complete and compliant product development lifecycle., * Conduct design quality gap assessments across software, design controls, risk management, and DHF documentation.

• Evaluate the alignment between product risks, design requirements, implementation, and verification/validation evidence.
• Review design documentation for completeness, consistency, traceability, and regulatory compliance.
• Partner with Software Engineering, R&D, Systems Engineering, Testing, Quality, and Regulatory teams to identify and resolve design quality gaps.
• Support CAPA, root cause analysis, change control, and systemic corrective actions.
• Identify process weaknesses and implement sustainable design quality improvements.
• Support regulatory audits, remediation activities, and inspection readiness.
• Develop and improve design quality procedures, standards, and work instructions.

• Bachelor’s degree in engineering, Computer Science, Software Engineering, or a related technical discipline.
• 5+ years of relevant experience in Design Quality, Software Quality, Systems Quality, or Quality Assurance within the medical device industry.
• Strong understanding of medical device design controls, software lifecycle processes, and risk management.
• Experience with design inputs/outputs, requirements traceability, verification and validation, and DHF documentation.
• Working knowledge of IEC 62304 and medical device quality system requirements.
• Experience conducting design quality gap assessments and supporting CAPA and root cause analysis.
• Ability to assess design quality holistically rather than focusing solely on individual test cases or verification activities.
• Strong analytical, documentation, problem-solving, and cross-functional communication skills.