Quality Design Assurance Engineer

Egg Medical is an innovative leader in radiation safety protection technology based in Minnesota. Our mission is to protect healthcare professionals from occupational radiation exposure while enabling the delivery of exceptional patient care.

About the Role

We are seeking a Quality Design Assurance Engineer to add to our team! This new position will support the management of our quality system while actively contributing to new product design and development initiatives. This role combines core quality engineering responsibilities with technical involvement in engineering projects to ensure our innovative medical devices meet the highest standards of safety, reliability, and regulatory compliance.

This role is based fully on-site at our Roseville, Minnesota headquarters and production facility. We are not open to relocation assistance for this position.

Responsibilities

• Quality System Support: Develop, implement, and maintain elements of the Quality Management System (QMS) to ensure ongoing compliance with FDA regulations, ISO 13485, and other applicable standards.
• New Product Development & Design Control: Collaborate with R&D, engineering, and cross-functional teams on new design projects; support design inputs/outputs, risk assessments (e.g., FMEA, ISO 14971), design verification and validation activities, and design reviews/transfer to manufacturing.
• Risk Management & Technical Reviews: Perform and document risk analyses, participate in technical design reviews, and ensure design controls are effectively applied throughout the product lifecycle.
• Non-Conformance & Corrective Actions: Investigate non-conformances, lead root cause analysis, and implement corrective and preventive actions (CAPA) to drive continuous improvement and prevent recurrence.
• Documentation & Compliance: Maintain accurate quality records, support internal/external audits, and contribute to regulatory submissions as needed.
• Continuous Improvement: Identify opportunities to improve quality processes, product designs, and overall efficiency; partner with engineering and other teams on quality initiatives.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Quality Engineering, or a related field.
• 3+ years of experience as a Quality Engineer in a regulated industry, preferably medical devices.
• Experience with FDA regulations, ISO 13485, and other medical device quality standards.
• Proficiency in quality tools and methodologies (e.g., FMEA, SPC, CAPA).
• Ability to work full-time on-site in Roseville, MN headquarters.
• Background check and drug test are required upon a job offer.

Pay range and compensation package

Full-time position with salary range from $100,000-$115,000, depending on experience.

• Additional bonus/incentive compensation available.
• Company laptop provided.
• Insurance available on the 1st of the month following date of hire, including: health, dental and vision insurance, plus pre-tax or Roth 401k available after 30 days.
• PTO accrues starting at 15 days, plus 11 company paid holidays.