Design Assurance Engineer

Our client is currently seeking a Quality Design Assurance Engineer to build out their Quality Operations engineering team. This opportunity allows you to cement yourself into a newly established office in Minneapolis working alongside the Senior Director of Quality.

This opportunity is currently Remote as the client is still in the process of building out their office. This role will eventually transition into a Hybrid schedule, so candidates must be located in the Greater Minneapolis area or willing to relocate.

Day to day you will:

• Provide insight and guidance to the design and development of new products, supporting the development of viable production processes under development
• Actively lead formal process validations and design verification/validation activities to ensure their compliance to protocols
• Coordinate and manage suppliers engineering change orders including reviewing testing strategy, review of reports and implementation plan

You should apply if you have:

• 5+ years of Design Assurance experience or other relevant experience
• Bachelors degree in a relevant discipline
• Extensive knowledge of new product development, design controls, risk management, and design history file (DHF) maintenance activities
• Ideally have experience adhering to EU MDR