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.