Design Quality Engineer

Integrated Resources, Inc ( IRI ); Maple Grove (MN); Hybrid; USD 80,000 - 100,000; Full time

Job summary

A medical device company in Maple Grove, MN is seeking a Sustaining Systems Design Quality Engineer II to ensure product safety and compliance. This hybrid role involves managing design change projects and working with cross-functional teams. Required qualifications include a Bachelor’s degree in Engineering and 3–5 years of design quality engineering experience. The position is a 12-Month W2 Contract with strong potential for full-time conversion, featuring a work schedule of 3 days onsite and 2 days remote.

Qualifications

• 3–5 years of experience in a design quality engineering role.
• Proven experience with Hazard Analysis and Risk Controls.
• Strong collaboration and communication skills.

Responsibilities

• Lead and manage design change projects including scoping and assessment.
• Create and maintain Design History Files and documentation.
• Author and execute Design Verification and Validation testing protocols.

Skills

Hazard Analysis

Risk Management

DFMEA

Complaint Analysis

Design Control

Collaboration

Communication

Education

Bachelor’s degree in Mechanical, Electrical, or Biomedical Engineering

Job description

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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.

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 (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.

Details

• Location: Hybrid – Maple Grove, MN
• Work Schedule: 3 Days Onsite / 2 Days Remote
• Duration: 12-Month W2 Contract (High Possibility of Full-Time Conversion)
• Seniority level: Mid-Senior level
• Employment type: Contract
• Job function: Science, Research, and Engineering
• Industries: Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing

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