About this role
Design Assurance Engineer II-1 at Bracco. Location: Eden Prairie, Minnesota, United States. Role: leading verification, conducting validation, managing risk Requirements: B.S. in engineering or computer science, 3+ years quality engineering in medical device industry, strong knowledge of ISO 13485 and 21 CFR 820, risk management (ISO 14971), quality tools, and strong written/verbal communication. Category: Quality Assurance Seniority: Mid Level Tools: ISO 13485, 21 CFR 820, ISO 14971, Six Sigma, DOE, FMEA, FTA, IEC 60601, UL Standards, AAMI TIR 36, EN 62304, EN 62366, EN 82304, IEC/TR 80002-1, 21 CFR Part 11, IPSE GAMP, SDLC, Agile, HIPAA, GDPR Commitment: Full Time Workplace: Onsite Languages: English