Design Quality Engineer(Software Remediation)

Job Title: Design Quality Engineer Software Remediation

Duration: 12 Months

Location: Minnesota

Employment Type: Contract W2

Pay Rate: $45/hour(DOE) on W2

Job Summary

We are seeking an experienced Design Quality Engineer Software Remediation to support a major software and design remediation initiative within a regulated medical device organization.

The ideal candidate will have a strong background in Design Quality, Software Quality, Systems Quality, or Medical Device Quality and the ability to evaluate the complete product development lifecycle from a design and risk perspective.

This position requires a holistic, end-to-end approach to design quality, connecting risk management, design controls, design inputs, requirements, design outputs, implementation, verification and validation, traceability, and the Design History File (DHF).

The role is not limited to reviewing individual requirements, specifications, or test cases. The engineer will evaluate whether the overall design and quality approach adequately addresses product and software risks, identify gaps and disconnects, and drive sustainable remediation.

The engineer will collaborate closely with Software Engineering, R&D, Systems Engineering, Quality, Regulatory, Testing, and other cross-functional teams to assess design decisions, quality risks, documentation, and objective evidence.

Key Responsibilities

Support large-scale software and design remediation initiatives.

Perform end-to-end design quality gap assessments across risk management, design controls, requirements, verification, validation, traceability, and DHF documentation.

Review risk assessments, hazards, mitigations, and their connection to design requirements and verification activities.

Evaluate the logical progression from risk assessment through design requirements, implementation, verification, and validation.

Assess whether requirements and verification activities adequately address identified product and software risks.

Review Design History Files (DHF) for completeness, consistency, traceability, and alignment with the overall design and risk strategy.

Identify disconnects between risk management, requirements, design documentation, testing, and objective evidence.

Work closely with Software Developers, Software Test Engineers, Systems Engineers, R&D Engineers, Quality, Regulatory, and other technical stakeholders.

Evaluate design decisions and determine whether verification activities appropriately demonstrate that identified risks have been addressed.

Identify systemic gaps in design controls and product development processes.

Support the development and implementation of global design quality processes, procedures, standards, and work instructions.

Evaluate remediation activities from an end-to-end quality perspective and ensure corrective actions address underlying design and process issues.

Support CAPA, root cause analysis, change control, and systemic corrective actions related to design and software quality.

Apply structured problem-solving methodologies, including 5 Whys, to identify root causes and sustainable corrective actions.

Review design documentation and objective evidence to ensure the overall design history is logical, complete, consistent, and defensible.

Support audits, remediation programs, and regulatory inspection readiness related to software-enabled medical devices.

Help establish standardized design quality processes across global R&D and product development organizations.

Influence cross-functional teams without direct authority and communicate quality expectations to both technical and non-technical stakeholders.

Required Qualifications

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

5+ years of experience in Design Quality, Software Quality, Systems Quality, Software Engineering, or Quality Assurance within a regulated medical device environment.

Strong understanding of medical device design controls and product development processes.

Experience with risk management, design inputs and outputs, requirements, verification, validation, traceability, and Design History File documentation.

Strong understanding of IEC 62304 and software lifecycle processes within a medical device environment.

Experience performing design or quality gap assessments and identifying disconnects across the product development lifecycle.

Ability to evaluate the relationship between risk assessment, design controls, design inputs, design outputs, requirements, implementation, verification and validation, traceability, and Design History File documentation.

Experience working directly with developers, testers, engineers, and cross-functional technical teams to evaluate design and quality issues.

Strong understanding of software risk management and how software risks connect to system- and product-level risks.

Experience with CAPA, root cause analysis, change control, and quality system processes.

Ability to look beyond individual requirements or test cases and evaluate whether the overall design and quality approach is appropriate and complete.

Strong analytical, problem-solving, and critical-thinking skills.

Strong written and verbal communication skills.

Ability to influence cross-functional and global stakeholders without direct authority.

Preferred Qualifications

Previous experience supporting design remediation, software remediation, or quality system remediation within a medical device organization.

Experience with Design History Files (DHF) and design assurance activities.

Experience performing holistic design quality assessments rather than narrowly focused verification reviews.

Experience evaluating risk management files and their connection to design controls, requirements, and verification evidence.

Experience developing or implementing global design quality processes, procedures, standards, or work instructions.

Experience supporting FDA audits, remediation programs, or regulatory inspection readiness.

Working knowledge of ISO 13485, FDA 21 CFR 820, IEC 62304, and applicable medical device quality requirements.

Experience with complex medical devices, embedded software, software-enabled products, or multidisciplinary R&D systems.

Experience with tools such as Jira, Jama, Bitbucket, or other requirements, software lifecycle, configuration management, or quality systems.

Experience identifying systemic design and process issues and implementing sustainable corrective actions.

Key Skills

Design Quality Engineer, Software Remediation, Software Quality, Medical Device, Design Controls, IEC 62304, Design History File, DHF, Risk Management, CAPA, FDA, ISO 13485, Requirements, Verification and Validation, Traceability, Design Assurance, Quality Engineering, Systems Engineering, Medical Device Software.