Design Assurance Engineer

My name is Jahera, and I’m reaching out from Intellectt Inc. regarding a Design Assurance Engineer contract opportunity in Minnesota (Hybrid – 3 days onsite) with one of our leading clients. Job Title: Design Assurance Engineer Location: Minnesota (Hybrid – 3 days onsite) Job Description: We are seeking an experienced Design Assurance Engineer to support design control and risk management activities within a cardiovascular medical device environment. The role focuses on remediation of existing quality documentation, design verification and validation, risk management, and ongoing product development activities. Key Responsibilities: Review and remediate design control and risk management documentation. Lead Test Method Validation (TMV) and support test method development. Develop and update FMEAs, hazard analyses, and risk management documentation. Ensure compliance with ISO 13485, ISO 14971, FDA requirements, and internal quality procedures. Support design verification, validation, design reviews, and PDP/NPD activities. Own or support CAPAs and NCRs as needed. Requirements: 5+ years of Medical Device Design Quality / Design Assurance experience. Strong experience in design controls, risk management, and remediation. Experience with ISO 13485, ISO 14971, FMEA, and TMV. Experience supporting PDP/NPD activities. #J-18808-Ljbffr Intellectt Inc