Design Assurance Engineer

Principal Design Quality Engineer – Cardiology Division

Location: Maple Grove, MN (Weaver Lake Road campus, hybrid – minimum 3 days onsite)

Duration: 3-Months

Pay Range: $65- $80/hour; the rate may be negotiable based on experience, education, geographic location, and other factors.

We are seeking a Principal Design Quality Engineer to support high‑visibility development projects within the cardiology division. This role provides quality and compliance expertise to cross‑functional teams, ensuring design history files are robust, risk management deliverables are complete, and remediation needs are effectively triaged.

• Apply in‑depth knowledge of Design Control and Risk Management to provide quality and compliance input across development projects.
• Assess adequacy of test method validation coverage, documentation, and execution.
• Independently evaluate design requirements, risk controls, and design history file documentation, including user needs, hazard analyses, and design verification deliverables.
• Utilize systematic problem‑solving methodologies to identify, prioritize, and resolve quality issues.
• Maintain compliance with the Quality Policy and all documented quality processes, demonstrating a primary commitment to patient safety and product quality.

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
• Minimum 8 years of experience in design assurance, quality, or related regulated industry.
• Proven experience in new product development
  , including risk management deliverables (plans/reports, hazard analysis, task analysis, DFMEA), test method validation, and design verification/validation.
• Strong understanding of ISO 13485, ISO 14971, CFRs, and Quality System Regulations
  .
• Excellent organizational, planning, and communication skills (written & verbal).
• Demonstrated use of quality tools and methodologies.

• Experience developing test methods and facilitating problem‑solving processes.
• Effective collaborator in both team and self‑directed environments.
• Ability to work with global teams across R&D, Process Development, Manufacturing, and other functions.
• Experience with Class III medical devices
  .