Design Engineer II

Job Title : Sustaining Systems Design Quality Engineer II

Location : 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 documentation .
• Develop and update Risk Management Files , including Hazard Analysis , Task Analysis , and Design FMEA .
• Author and execute Design Verification , Validation , and Usability testing protocols and reports.
• Support complaint investigations , NCEPs , CAPAs , and PIRs with design quality expertise.
• Apply structured problem-solving methodologies to resolve product and process issues.
• Ensure compliance with internal quality procedures , regulatory standards , and design control requirements .

Required Qualifications :

Preferred Qualifications :