Design Quality Engineer

Role: Design Quality Engineer (Software Remediation)
Duration:12 months
Location: Saint Paul,MN
Pay Rate: $45 - 50/hr on W2

Overview
We are seeking a Design Quality Engineer to support a major software and design remediation initiative within a regulated medical device organization. This individual will take a holistic, end-to-end view of design quality, working across Software Engineering, R&D, Systems, Quality, Regulatory, and other cross-functional teams to assess design processes, identify gaps, and drive sustainable remediation.

This role is not focused solely on software verification, individual requirements, or test cases. The ideal candidate will understand how requirements, risks, design inputs and outputs, verification activities, traceability, change control, and the Design History File (DHF) connect throughout the product development lifecycle.

The individual will be expected to connect the dots across the design process, evaluate whether the overall design and quality approach makes sense, and identify gaps that may not be apparent when reviewing an individual specification or test case in isolation.

The ideal candidate brings a strong quality and design assurance mindset and is comfortable walking through a product from a risk and design perspective - understanding the relationship between risk assessment, design controls, requirements, architecture, implementation, verification, validation, and the DHF.

This person will work directly with developers, testers, engineers, and quality professionals to evaluate whether the design and supporting documentation adequately address identified risks and applicable quality requirements. They must be comfortable asking questions, challenging assumptions, performing gap assessments, and determining the logical progression from risk ? design ? requirements ? implementation ? verification ? evidence.

Key Responsibilities
Support a large-scale design and software remediation program focused on identifying and closing gaps across design quality processes, documentation, and design controls.
Take a holistic view of product and software design quality, evaluating the complete design process rather than focusing exclusively on individual requirements, specifications, or test cases.
Perform detailed gap assessments across design documentation, risk management, design controls, traceability, verification, and the Design History File (DHF).
Walk through risk assessments to understand identified hazards, risks, mitigations, and how those risks are translated into design requirements and ultimately addressed through verification and validation.
Evaluate the logical progression between risk assessments, design inputs, design outputs, requirements, implementation, verification, and validation.
Assess whether requirements and verification activities adequately address the underlying design and product risks - not simply whether an individual test case has been completed.
*Review and assess Design History File (DHF) documentation for completeness, consistency, traceability, and alignment with the overall design and risk strategy.*
Provide design assurance and quality oversight throughout the product development and remediation lifecycle.
Partner closely with Software Developers, Software Test Engineers, Systems Engineers, R&D Engineers, Quality, Regulatory, and other technical stakeholders to evaluate design decisions and quality risks.
Work directly with developers and testers to understand how design decisions are implemented and determine whether verification activities appropriately demonstrate that identified risks have been addressed.
Identify disconnects between risk management, requirements, design documentation, testing, and objective evidence and drive appropriate remediation.
Assess whether existing design controls and development processes are functioning as intended and identify systemic gaps.
Support development and implementation of global design quality processes, procedures, standards, and work instructions.
Evaluate remediation activities from an end-to-end quality perspective, ensuring individual corrective actions address the underlying process or design issue rather than simply closing a documentation gap.
Support CAPA, root cause analysis, and systemic corrective actions related to design and software quality issues.
Apply structured problem-solving methodologies, including 5 Whys, to identify root causes and determine sustainable corrective actions.
Review design documentation and objective evidence to determine whether the overall design history tells a logical, complete, and defensible story.
Identify gaps where documentation, requirements, risk assessments, design decisions, or verification evidence do not adequately connect.
Support audits, remediation activities, and regulatory inspection readiness related to design quality and software-enabled medical devices.
Help establish standardized processes that can be consistently applied 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 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 working with risk management, design inputs/outputs, requirements, verification, validation, traceability, and DHF 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 & Validation
Traceability

Design History File
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 and critical-thinking skills with the ability to connect information across multiple technical and quality disciplines.
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.