Design Quality Engineer III - Medical Device (Hybrid - Maple Grove, MN) Contract

Overview

The Design Quality Engineer will support the application of design controls to projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and improvements for manufacturability and cost reduction. This individual will work with a cross-functional team to ensure safety, quality, and compliance of products. Imaging diagnostic catheter design changes. Working with a team of 5 Design Assurance engineers. Total team of 20.

Responsibilities

• Ownership of design change projects including scoping, assessment, and implementation.
• Develop, update, and maintain Design History File and Design Input / Output documentation
• Develop, update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
• Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
• Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Build Quality into all aspects of work by maintaining compliance to all quality requirements.

Qualifications

Other Details

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