Support and lead Design History File (DHF) Remediation activities for sustaining medical device products. Perform gap assessments, evidence collection, documentation updates, and design control remediation.
Numbers & Facts
Location
Maple Grove, MN
Salary
$50–$54.58 Per Hour
Description
Job Title: Design Quality Engineer III
Job ID: 19152-1
Location: Maple Grove, MN 55311 Onsite
Duration: 12+ Months
Payrate: $50.00 - $54.58/HR. on W2
Core Responsibilities
Support and lead Design History File (DHF) Remediation activities for sustaining medical device products.
Perform gap assessments, evidence collection, documentation updates, and design control remediation.
Create/update:
Design Inputs & Outputs
Product Specifications
Component Specifications
Engineering Drawings/Prints
Design Review Documentation
Verification & Validation (V&V) Traceability
Maintain end-to-end traceability between:
Design Inputs
Design Outputs
Risk Controls
Verification
Validation
Lead updates to DFMEA and Hazard Analysis documentation.
Support audit/inspection readiness and regulatory compliance.
Collaborate with R&D, Manufacturing, Regulatory Affairs (RA), Document Control, and Quality teams.
Must-Have Skills
3+ years of Medical Device Industry experience.
Strong knowledge of Design Controls.
Experience with:
Design History Files (DHF)
Design Inputs/Outputs
Product Specifications
Component Specifications
Engineering Drawings/Prints
Experience maintaining:
DFMEA
Hazard Analysis
Risk Management Documentation
Understanding of:
Verification & Validation (V&V)
Traceability Matrices
FDA/ISO Medical Device Design Control Requirements