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Sustaining Systems Design Quality Engineer II Job Opening In Maple Grove Minnesota – Now Hiring Integrated Resources, Inc


Job description

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:


  • 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.



Required Skill Profession

Other General


  • Job Details

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Unlock Your Sustaining Systems Potential: Insight & Career Growth Guide


Real-time Sustaining Systems Jobs Trends (Graphical Representation)

Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph here. Uncover the dynamic job market trends for Sustaining Systems in Maple Grove, Minnesota, United States, highlighting market share and opportunities for professionals in Sustaining Systems roles.

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Are You Looking for Sustaining Systems Design Quality Engineer II Job?

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The Work Culture

An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Integrated Resources, Inc adheres to the cultural norms as outlined by Expertini.

The fundamental ethical values are:

1. Independence

2. Loyalty

3. Impartiapty

4. Integrity

5. Accountabipty

6. Respect for human rights

7. Obeying United States laws and regulations

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The average salary range for a varies, but the pay scale is rated "Standard" in Maple Grove Minnesota. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.

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