Design Quality Engineer

Job Title: Design Quality Engineer



Location: Minnesota



Duration: 12 Months



Pay Rate: $49 $52/hr W2



Industry: Medical Device

Job Description:
Seeking an experienced Design Quality Engineer to support a large-scale software and design remediation program within a regulated medical device environment. The role requires a holistic understanding of Design Controls, software lifecycle processes, risk management, requirements, traceability, V&V, and DHF documentation.

Key Responsibilities:

• Support design and software remediation activities across the medical device product lifecycle.
• Perform gap assessments across Design Controls, risk management, requirements, traceability, V&V, and DHF documentation.
• Evaluate the relationship between risks, design inputs/outputs, requirements, implementation, verification, and validation.
• Review DHF documentation for completeness, consistency, traceability, and regulatory compliance.
• Identify gaps between risk management, requirements, design documentation, testing, and objective evidence.
• Partner with Software, Systems, R&D, Quality, and Regulatory teams to drive remediation activities.
• Support CAPA, root cause analysis, change control, and sustainable corrective actions.
• Support design quality procedures, standards, audit readiness, and regulatory inspection readiness.

Required Qualifications:

• Bachelor's degree in Engineering, Computer Science, Software Engineering, or related technical discipline.
• 5+ years of Design Quality, Software Quality, Systems Quality, Software Engineering, or QA experience in the medical device industry.
• Strong hands-on knowledge of Medical Device Design Controls and IEC 62304.
• Experience with DHF, risk management, design inputs/outputs, requirements, traceability, and V&V.
• Experience performing design/software quality gap assessments.
• Strong understanding of software risk management and medical device software lifecycle processes.
• Experience with CAPA, RCA, change control, and Quality Systems.
• Strong cross-functional communication and analytical/problem-solving skills.