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Integrated Resources, Inc ( IRI )
Design Quality Engineer

Design Quality Engineer

Hybrid

Maple grove, United states

$ 43 /hour

Junior

Freelance

28-09-2025

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Skills

Communication Risk Management Quality Assurance Problem-solving

Job Specifications

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)

HM NOTE:

**Want to see more design quality experience - not just manufacturing quality.
**Need: hazard analysis, risk controls, DFMEA, complaint analysis, NCEP/CAPA experience.

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:

Bachelor's degree in mechanical, Electrical, or Biomedical Engineering (must be listed on resume).
3-5 years of experience in a design quality engineering role (not manufacturing-focused).
Proven experience with:
Hazard Analysis and Risk Controls
Design Failure Mode and Effects Analysis (DFMEA)
Complaint Analysis, NCEP, and CAPA management
Design control within the medical device industry
Strong collaboration and communication skills (both verbal and written).
Demonstrated ability to work independently and in cross-functional team settings.

Preferred Qualifications:

Prior experience working with medical electrical systems or cardiology-related devices.
Familiarity with FDA regulations, ISO 13485, and IEC 60601 standards.

About the Company

Integrated Resources Inc. (IRI) is a professional staffing firm specializing in contract, consulting & full time positions in the area of Information Technology, Life Science and Allied Healthcare. Since its inception in 1996, IRI has continued to grow in size, opportunities, service and quality. Our expert team of highly trained counselors work hand in hand with every candidate and client forming a partnership of understanding and commitment. Know more