AT
Design Assurance Engineer
Accepting applicationsAdvantage Technical · Maple Grove, MN
Full-Time Associate aiateganperl
Posted
2d ago
Category
Test
Experience
Associate
Country
United States
Senior Design Assurance Engineer – DHF Remediation
Location: Maple Grove, MN
Duration: 12-Month Contract with opportunity to extend
Pay Rate: Up to $54.00 an hour or about $109,000 a year
Work Authorization: Applicants must be authorized to work in the United States without current or future visa sponsorship.
Position Summary
We are seeking an experienced Design Assurance Engineer to support a high-priority Design History File (DHF) remediation initiative for sustaining medical devices. This role will serve as a key Quality representative, partnering with cross-functional teams to assess, update, and maintain design control documentation while ensuring compliance with internal quality systems and regulatory requirements.
The ideal candidate will have strong experience with design controls, risk management, DHF documentation, and Medical Electrical Equipment (MEE). This individual will play a critical role in ensuring remediated DHFs are complete, traceable, inspection-ready, and aligned with current regulatory expectations.
Key Responsibilities
DHF Remediation & Design Controls
Support Design History File (DHF) remediation activities, including gap assessments, evidence collection, and documentation updates.
Assist in defining remediation scope, assumptions, acceptance criteria, and strategies for leveraging legacy evidence.
Create, revise, and maintain DHF documentation, including:
Design Inputs
Design Outputs
Design Reviews
Verification and Validation Documentation
Traceability Matrices
Identify documentation gaps and determine when additional testing, reviews, or documentation updates are required.
Risk Management
Maintain and update product risk management documentation, including:
Design Failure Mode and Effects Analysis (DFMEA)
Hazard Analysis
Ensure risk controls are properly linked to design inputs, outputs, verification, validation, labeling, and post-market data.
Drive alignment between risk management files and remediated design documentation.
Traceability & Compliance
Support end-to-end traceability between design requirements, risk controls, design outputs, verification, and validation activities.
Document and help resolve traceability gaps and compliance issues.
Coordinate with R&D, Manufacturing, Regulatory Affairs, and Document Control to ensure documentation is reviewed, approved, and maintained within quality systems.
Audit & Inspection Readiness
Organize objective evidence supporting remediation activities.
Prepare summaries and rationale for remediation decisions.
Support internal and external audits by assisting with responses to auditor inquiries.
Ensure DHFs remain inspection-ready and compliant with applicable regulations.
Quality Engineering Support
Apply systematic problem-solving methodologies to identify and resolve quality and compliance issues.
Maintain remediation trackers, gap assessments, action item lists, and evidence inventories.
Communicate project status, risks, and roadblocks to project stakeholders and leadership.
Support quality initiatives that drive compliance, product quality, and patient safety.
Required Qualifications
Bachelor's degree in Engineering or a related technical discipline.
Minimum of 3 years of experience within the medical device industry.
Experience supporting Medical Electrical Equipment (MEE) products.
Strong understanding of Design Controls and Design Assurance principles.
Experience developing, updating, and maintaining:
Design History Files (DHFs)
Design Inputs and Outputs
Product Specifications
Component Specifications
Engineering Drawings/Prints
Experience maintaining and updating risk management documentation, including DFMEA and Hazard Analysis.
Knowledge of FDA Quality System Regulations, ISO 13485, and medical device design control requirements.
Strong technical writing, documentation, and cross-functional communication skills.
Must-Have Experience In
Design Controls
Design History Files (DHF)
Risk Management (DFMEA/Hazard Analysis)
Medical Electrical Equipment (MEE)
Medical Device Industry Experience
Preferred Qualifications
Previous experience supporting DHF remediation or design control remediation projects.
Experience supporting regulatory inspections and audits.
Familiarity with traceability matrix development and verification/validation evidence mapping.
Experience working with sustaining or legacy medical device products.
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Location: Maple Grove, MN
Duration: 12-Month Contract with opportunity to extend
Pay Rate: Up to $54.00 an hour or about $109,000 a year
Work Authorization: Applicants must be authorized to work in the United States without current or future visa sponsorship.
Position Summary
We are seeking an experienced Design Assurance Engineer to support a high-priority Design History File (DHF) remediation initiative for sustaining medical devices. This role will serve as a key Quality representative, partnering with cross-functional teams to assess, update, and maintain design control documentation while ensuring compliance with internal quality systems and regulatory requirements.
The ideal candidate will have strong experience with design controls, risk management, DHF documentation, and Medical Electrical Equipment (MEE). This individual will play a critical role in ensuring remediated DHFs are complete, traceable, inspection-ready, and aligned with current regulatory expectations.
Key Responsibilities
DHF Remediation & Design Controls
Support Design History File (DHF) remediation activities, including gap assessments, evidence collection, and documentation updates.
Assist in defining remediation scope, assumptions, acceptance criteria, and strategies for leveraging legacy evidence.
Create, revise, and maintain DHF documentation, including:
Design Inputs
Design Outputs
Design Reviews
Verification and Validation Documentation
Traceability Matrices
Identify documentation gaps and determine when additional testing, reviews, or documentation updates are required.
Risk Management
Maintain and update product risk management documentation, including:
Design Failure Mode and Effects Analysis (DFMEA)
Hazard Analysis
Ensure risk controls are properly linked to design inputs, outputs, verification, validation, labeling, and post-market data.
Drive alignment between risk management files and remediated design documentation.
Traceability & Compliance
Support end-to-end traceability between design requirements, risk controls, design outputs, verification, and validation activities.
Document and help resolve traceability gaps and compliance issues.
Coordinate with R&D, Manufacturing, Regulatory Affairs, and Document Control to ensure documentation is reviewed, approved, and maintained within quality systems.
Audit & Inspection Readiness
Organize objective evidence supporting remediation activities.
Prepare summaries and rationale for remediation decisions.
Support internal and external audits by assisting with responses to auditor inquiries.
Ensure DHFs remain inspection-ready and compliant with applicable regulations.
Quality Engineering Support
Apply systematic problem-solving methodologies to identify and resolve quality and compliance issues.
Maintain remediation trackers, gap assessments, action item lists, and evidence inventories.
Communicate project status, risks, and roadblocks to project stakeholders and leadership.
Support quality initiatives that drive compliance, product quality, and patient safety.
Required Qualifications
Bachelor's degree in Engineering or a related technical discipline.
Minimum of 3 years of experience within the medical device industry.
Experience supporting Medical Electrical Equipment (MEE) products.
Strong understanding of Design Controls and Design Assurance principles.
Experience developing, updating, and maintaining:
Design History Files (DHFs)
Design Inputs and Outputs
Product Specifications
Component Specifications
Engineering Drawings/Prints
Experience maintaining and updating risk management documentation, including DFMEA and Hazard Analysis.
Knowledge of FDA Quality System Regulations, ISO 13485, and medical device design control requirements.
Strong technical writing, documentation, and cross-functional communication skills.
Must-Have Experience In
Design Controls
Design History Files (DHF)
Risk Management (DFMEA/Hazard Analysis)
Medical Electrical Equipment (MEE)
Medical Device Industry Experience
Preferred Qualifications
Previous experience supporting DHF remediation or design control remediation projects.
Experience supporting regulatory inspections and audits.
Familiarity with traceability matrix development and verification/validation evidence mapping.
Experience working with sustaining or legacy medical device products.
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