Design Engineer II

Job Title: Sustaining Systems Design Quality Engineer IILocation: Hybrid - Maple Grove, MN Work Schedule: 3 Days Onsite / 2 Days Remote Duration: 12-Month W2 Contract (High Possibility of Full-Time Conversion) Pay Rate: $43.38/hour (W2)Position Overview:Client is seeking a Sustaining Systems Design Quality Engineer II to join our Interventional Cardiology (IC) division in Maple Grove, MN. This hybrid role supports design quality assurance for medical electrical equipment/systems (MEE). You will contribute to sustaining engineering initiatives by ensuring product safety, compliance, and continuous improvement in collaboration with cross-functional teams.Key Responsibilities:Lead and manage design change projects including scoping, assessment, and implementation.Create and maintain Design History Files, and Design Input/Output documentationDevelop and update Risk Management Files, including Hazard AnalysisTask Analysis, and Design FMEAAuthor and execute Design VerificationValidation, and Usability testing protocols and reports.Support complaint investigationsNCEPsCAPAs, and PIRs with design quality expertise.Apply structured problem-solving methodologies to resolve product and process issues.Ensure compliance with internal quality proceduresregulatory standards, and design control requirementsRequired Qualifications:Bachelor's degree in mechanical, Electrical, or Biomedical Engineering (must be listed on resume).3-5 years of experience in a design quality engineering role (not manufacturing-focused).Proven experience with:Hazard Analysis and Risk ControlsDesign Failure Mode and Effects Analysis (DFMEA)Complaint AnalysisNCEP, and CAPA managementDesign control within the medical device industryStrong collaboration and communication skills (both verbal and written).Demonstrated ability to work independently and in cross-functional team settings.Preferred Qualifications:Prior experience working with medical electrical systems or cardiology-related devicesFamiliarity with FDA regulationsISO 13485, and IEC 60601 standards

Created: 2025-10-02