Engineer - Quality Engineer II Quality Engineer II

US Tech Solutions • Maple Grove, MN • 4h ago

Duration: 12 Months (with possible extension)

Hybrid - Three Days Onsite

Job Purpose

Client is currently recruiting for a Sustaining Systems Design Quality Engineer II in our Maple Grove, MN location.

This is an exciting opportunity to participate in the quality assurance of our medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of ***.

The Design Quality Engineer II will support 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 high-performance cross-functional team to ensure safety, quality, and compliance of products.

Key Responsibilities

Ownership of design change projects including scoping, assessment, and implementation.

Develop, update, and maintain Design History File and Design Input / Output documentation

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.

Qualifications:

3-5 Years with BS. Degree must be clearly stated on resume.

Bachelor's degree in mechanical, electrical, or biomedical engineering, highly preferred

Experience with design control, risk management, and medical device standards compliance

Experience with corrective and preventive action (CAPAs)

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To learn more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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