Quality Engineer || St. Paul Area, Minnesota

Position: Quality Engineer – Design Controls & DHF Remediation location: St. Paul Area, Minnesota (Onsite) Job Type: 12+ months (Contract)Job DescriptionFocus Areas: Design Controls Capital Equipment (MEE) DHF RemediationProject: Supporting “Project Guardian” Design Assurance activitiesRole OverviewThis role is ideal for a detail‑driven Quality Engineer who thrives in a regulated medical‑device environment and enjoys working at the intersection of design controls, risk management, and product sustaining engineering. You will play a key role in ensuring that Design History Files (DHFs) are complete, compliant, and inspection‑ready while supporting cross‑functional teams in closing documentation gaps and strengthening product quality.You’ll contribute directly to the reliability, safety, and compliance of capital equipment products by applying strong design‑control knowledge, risk‑management expertise, and structured problem‑solving.Required Qualifications3+ years of experience in the medical‑device industryCapital equipment / MEE experience (required)Strong understanding of design controls, including DHF creation and maintenanceExperience with Design Inputs/Outputs, specifications, and engineering printsExperience updating and maintaining DFMEA and Hazard Analysis documentationFamiliarity with regulated quality systems and documentation practicesKey ResponsibilitiesDHF Remediation — Support gap assessments, evidence collection, and documentation updates to resolve design‑control deficiencies.Remediation Planning — Help define scope, assumptions, and acceptance criteria for legacy evidence; escalate when additional testing or documentation is required.Design Documentation — Create or update design inputs/outputs, design reviews, V&V evidence mapping, and traceability matrices.Risk Management — Lead updates to Hazard Analyses and DFMEAs; ensure alignment between risk controls and remediated DHF content.Traceability — Support end‑to‑end traceability across inputs, outputs, risk controls, verification, and validation.Cross‑Functional Collaboration — Work with R&D, Manufacturing, Regulatory, and Document Control to route updates and maintain version‑controlled documentation.Audit & Inspection Readiness — Prepare objective evidence, remediation summaries, and responses to auditor questions.Problem Solving — Apply structured methodologies to identify and resolve documentation or compliance gaps.Project Support — Maintain trackers, action‑item logs, and evidence inventories; communicate risks and progress to project leads.What Success Looks LikeStrengthened DHF documentation that is complete, consistent, and inspection‑readyClear, accurate traceability across design controls and risk‑management elementsSmooth collaboration with cross‑functional partnersTimely closure of remediation tasks and deliverablesImproved compliance posture for capital equipment productsRole Expectations & Working StyleKnowledge & ExpertiseYou bring strong working knowledge of design controls, risk management, and medical‑device quality systems. You understand how design, manufacturing, and quality intersect—and how documentation supports product safety and compliance.Problem SolvingYou evaluate complex data sets, identify gaps, and recommend solutions using sound judgment a