Design Assurance Engineer

Scanlan Int'l • Saint Paul, MN

5h • $72,100 - $115,300 • Onsite

About The Position

The Design Assurance Engineer is part of the product design and development team and ensures quality and regulatory compliance throughout the medical device lifecycle for class I and II reusable surgical instruments and disposable medical devices and supports the implementation and management of the digital requirements management system.  This position reports to the Director of R&D Engineering.

Requirements

• Bachelor of Science in Mechanical Engineering or Biomedical Engineering
• Minimum of 3+ years design assurance or product development.
• Understanding of ISO 13485 and FDA 21 CFR 820 compliance.
• Experience with full design lifecycle and phase-gate processes.
• Understanding of FMEAs, DOEs and Risk Assessment methods
• Strong written and verbal skills for documentation, presentations, and team alignment.
• Problem-Solving & Critical Thinking: Analytical skills to identify gaps, assess risks, and draw conclusions.
• High degree of accuracy in documentation and reviews.
• Working effectively in cross-functional teams (design, manufacturing, regulatory).

Nice To Haves

• Experience in medical devices
• Jama Connect requirements management software
• Minitab statistical analysis software
• Knowledge of quality methodologies (Six Sigma, DFSS, DMAIC).
• Project Management, time management, prioritization, and execution.
• Leadership, mentoring, and fostering a quality culture.

Responsibilities

• Lead Design Assurance For Representation & Compliance
• Product Testing
• Risk Management & Reviews
• Technical Guidance & Design Principles

Benefits

• Medical, Dental, and Vision Insurance
• Group Life Insurance
• Short-Term Disability Insurance
• Long-Term Disability Insurance
• 401(k) Plan with Company Match
• Workers' Compensation
• Employee Assistance Program (EAP)
• Regular Part-Time Benefit Eligibility
• Training and Development Program
• Tuition Assistance Program
• Paid Time Off, including:
• Holidays
• Floating Holidays
• Vacation
• Earned Sick and Safe Time (ESST)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level