Principal Design Assurance Engineer

JCW is currently working on an exciting search for a Principal Design Assurance Engineer with a leading Biotech based in Minneapolis, MN. In this role you have the opportunity to be apart of a growing Quality Operations team working alongside the Senior Director of Quality.

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

For more information about this or other positions please contact Megan Harper at