Design Quality Engineer(Software Remediation)

The ideal candidate will have a strong Design Assurance / Software Quality background with hands-on experience evaluating end-to-end design processes and identifying systemic quality and compliance gaps. This role will focus on ensuring alignment across risk management, design controls, software requirements, design inputs/outputs, V&V, traceability, and Design History File (DHF) documentation.

Job Title: Design Quality Engineer Software Remediation
Location: Minnesota
Duration: 12 Months
Employment Type: Contract | W2
Pay Rate: $49/hr(DOE) on W2
Industry: Medical Device

Job Summary

We are seeking an experienced Design Quality Engineer to support a major software and design remediation program within a regulated medical device environment. This role will focus on ensuring alignment across risk management, design controls, software requirements, design inputs/outputs, V&V, traceability, and Design History File (DHF) documentation.

The ideal candidate will have a strong Design Assurance / Software Quality background with hands-on experience evaluating end-to-end design processes and identifying systemic quality and compliance gaps.

Job Description

• Perform design and software quality gap assessments across the product development lifecycle.

• Review DHF, design controls, risk management files, requirements, traceability, and V&V documentation.

• Evaluate the relationship between product/software risks, design requirements, implementation, and verification evidence.

• Identify gaps between risk assessments, design inputs/outputs, requirements, testing, and objective evidence.

• Support software/design remediation, CAPA, root cause analysis, and change control activities.

• Partner with Software, Systems, R&D, Quality, Regulatory, and Test Engineering teams to resolve design quality issues.

• Ensure remediation activities address underlying design/process issues and meet applicable medical device requirements.

• Support audit readiness and regulatory inspection activities for software-enabled medical devices.

Job Requirements

• Bachelor s degree in Engineering, Computer Science, Software Engineering, or a related technical discipline.

• 5+ years of Design Quality, Design Assurance, Software Quality, Systems Quality, or related medical device experience.

• Strong experience with medical device design controls and Design History Files (DHF).

• Strong knowledge of IEC 62304 and medical device software lifecycle processes.

• Hands-on experience with risk management, design inputs/outputs, requirements, V&V, and traceability.

• Experience with design/software remediation, gap assessments, CAPA, root cause analysis, and change control.

• Knowledge of ISO 13485, ISO 14971, and FDA Quality System requirements.

• Experience with complex medical devices, embedded software, or software-enabled products preferred.

• Familiarity with Jira, Jama, Bitbucket, or similar lifecycle/requirements management tools is a plus.

• Strong analytical, problem-solving, and cross-functional communication skills.