Sr. Mechanical R&D Engineer for Medtronic, Inc located in Jacksonville, FL. Responsible for providing R&D engineering support to ensure the successful development of Medtronic ENT (Ear, Nose & Throat) devices, design transfers, scale-up and ongoing operational support; work with Product Design and Quality control of Class II and Class III medical devices including capital powered equipment and sterile disposable equipment; navigate complex regulations including FDA Quality Systems Regulations (QSR) 21 CFR 820, ISO13485, ISO14971, and EU Medical Device Directive (MDD)/Medical Device Regulations (MDR); responsible for risk analysis activities including health hazard assessment, Fault Tree Analysis, Process Failure Mode Control Analysis, Design Failure Mode Control Analysis, and Corrective and Preventive Actions (CAPA); apply engineering analysis techniques and tools using Ansys, Minitab, CE Tol, and PTC Creo; coordinate Measurement System Analysis, Design of Experiments (DOE) and Statistical Process Control (SPC), Process Capability and Sampling Techniques; utilize Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP); and design cosmetic molded parts. Create engineering drawings for molded, sheet metal, machined, and off the shelf components using Geometric Dimensioning and Tolerancing (GD&T); and perform Engineering tolerance stack-ups using risk-based techniques and communicate design intent with manufacturers. Position works a hybrid model and will be onsite in Jacksonville, FL –3-4 days per week.