Design Assurance Engineer

Design Assurance Engineer III or Sr. Design Assurance Engineer | Direct Hire | $100-$127k + 10% Bonus | Fridley, MN A well known medical device company is seeking a Design Assurance Engineer III or Sr. Design Assurance Engineer to help support large projects for medical devices that are complex parts and tight specifications and be a part of the Design Quality Team that''s growing at a new R&D facility. This Engineer will have flexiblity, but mainly needs to be onsite. Represent Quality Assurance on product development teams, including developing Quality Plans and Risk Management PlansSupport design and development project deliverables related to Design Controls, Risk Management, Design Verification and Validation to ensure meet applicable standards and regulatory requirements while ensuring a primary focus on patient safety and reliable product performanceDesign and/or specify inspection and testing procedures/systems to ensure products conform to specifications and quality standardsInvestigate/analyze customer complaints and support Regulatory Affairs to monitor customer complaint trends and maintain compliance to complaint systemSupport all functional departments to ensure compliance with Quality System and lead continuous improvement efforts of the Quality System.Qualifications:BS or MS: Mechanical or Biomedical Engineering (Engineering realm required)5+ years as a Design Assurance Engineer Medical Device industry experience (ISO 13485) required! - provided by Dice

Created: 2025-09-06