Design Quality Engineer

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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.

• 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.

• 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.

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

• 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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