Sustaining Systems Design Quality Engineer II

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.