Design Quality Engineer

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
  .

Salary : $120,000 - $180,000