Principal Reliability Engineer

Job description

Position Description: Principal Reliability Engineer for Medtronic, Inc located in Billerica, MA. Responsible for providing quality engineering support to ensure the successful development of Medtronic medical products. Ensure design control requirements are met and products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. Update risk mgmt. documents to reflect updated or changed controls and mitigations, compliance evidence for standards, and risk estimates in response to post-market surveillance. Utilize Mechanical Geometric Dimensioning and Tolerancing (GD&T) and Root Cause Analysis (RCA). Navigate the complexities of government and industry regulations to include FDA 21 CFR Part 820, Current Good Manufacturing Practices (cGMP), ISO 14791, ISO 13485, ISO 9001, ISO 10012, and ISO 17025. Support various regulatory audits for Quality system process documents and records. Coordinate various Corrective & Preventive Actions (CAPA) programs as well as Lean Six Sigma, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP). Utilize risk analysis including Failure Mode Effect Analysis (F...