Quality Engineer- Minneapolis

Quality Engineer

EGG Medical is a Minnesota-based medical device company that designs, develops, and manufactures radiation protection systems. The company’s EggNest™ Radiation Protection System reduces radiation exposure for clinicians by up to 97% without compromising workflow. EGG Medical believes that all interventional physicians, nurses and techs deserve better protection from scatter radiation in the lab because #ScatterMatters!

Why You Should Join Us

This is a Quality Engineer role reporting to their new facility in Roseville, MN. In this role, you will play a critical role in ensuring the quality, reliability, and compliance of Egg Medical’s products. This position focuses on handling product returns, complaint management, field servicing, and customer support, in addition to core quality engineering responsibilities.

What You’ll Do

As a Quality Engineer, you will:

• Oversee the process for product returns, including investigation, root cause analysis, and resolution of customer complaints.

• Ensure timely and accurate documentation and reporting in compliance with regulatory requirements.

• Coordinate field service activities, including troubleshooting, repairs, and preventive maintenance.

• Develop, implement, and maintain quality control systems and processes to ensure product compliance with FDA, ISO 13485, and other relevant regulations. Perform risk assessments, validation, and verification activities for medical devices.

• Lead investigations into non-conformances and implement corrective and preventive actions (CAPA) to address quality issues and prevent recurrence.

• Maintain accurate records for quality processes, including complaints, returns, and servicing activities. Support internal and external audits to ensure adherence to regulatory standards.

• Identify opportunities to enhance product quality, streamline processes, and improve customer experience. Collaborate with cross-functional teams to drive quality initiatives.

What You’ll Need

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Quality Engineering, or a related field.

• Multiple years of experience as a Quality Engineer in a regulated industry, preferably medical devices.

• Experience in handling product returns, complaint management, and customer support.

• Familiarity with field servicing and technical support for medical devices is a plus.

• Experience with FDA regulations, ISO 13485, and other medical device quality standards.

• Proficiency in quality tools and methodologies (e.g., FMEA, SPC, CAPA).

Perks of the Job

Compensation: 

• Base: commensurate with experience

• Variable: 10% bonus

Other Benefits:

• Medical:

• • Health Partners Medical ($3,200 deductible plan, 100% coverage thereafter)

  • Dental and Vision (EyeMed) with an HSA (no corporate contribution to HSA). Company covers premiums at 85% for employee and 70% for dependents.

  • Vision plan is optional and paid 100% by the employee.

• 11 Paid holidays per year.

• 401K and Roth IRA (no company match).