Design Quality Engineer - (Minneapolis, MN)

Summary This position will be responsible for product remediation gap analysis and maintenance of the remediation process throughout the organization. Remediation engineering activities for selected products includes review and gap assessment of design qualifications, risk management, standards, component and system level specifications, test method validation, component/contract manufacturer qualification and process validation. Responsibilities Execute a risk based approach/procedure/plan for remediation of design qualifications/specifications, technical standards, test methods, supplier controls and manufacturing controls grounded in FDA qualifications and technical standards. Collaborate together with both internal groups and external groups to assess and potentially redefine or clarify system level qualifications, Use-Conditions and risks