Sr. Quality Engineer
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About The Position
The Sr. Quality Engineer for Medtronic, Inc located in Fridley, MN is responsible for the regulatory reporting of post market product performance to global external regulators. This role involves developing and maintaining cross-functional processes and practices to ensure on-time performance execution and product market access. The engineer will prepare post market surveillance deliverables and coordinate with technical and clinical experts across the operating unit to review all inputs to these deliverables. The position requires extensive product knowledge related to Implantable Class II and Class III medical devices, including implantable infusion systems, deep brain stimulation systems, neurostimulation systems for pain therapy, tibial nerve stimulation systems, and sacral nerve stimulation systems. Additionally, the engineer will handle deficiency responses for EU MDR (Medical Device Reporting) and annual certificate surveillance work with notified body TUV. The role also involves utilizing various software tools such as R Programming Language (UmpSoft complaint monitoring software), Track Wise, PTC Integrity, Agile, SAP, Enovia, and Documentum. The engineer will coordinate various Risk management activities following ISO 14971:2019 guidelines and be responsible for Post Market Surveillance Plans and Reports (PMS), Post Market Clinical Follow Ups (PMCFs), Periodic Safety Update Plan and Report (PSUR), and Product Surveillance Reports (PSR) supporting EU MDR Regulation 2017/745 and MDCG (Medical Device Coordination Group) 2022-2021 PSUR Guidance. The position will leverage Corrective and Preventive Actions (CAPA) and Field Corrective Actions (FCA) processes, and Quality System Regulation FDA 21 CFR Part 820 and ISO 13485. The engineer will also work on Complaints Management and FDA Medical Device Report Adverse Event codes as well as the Global Complaint Handling System. Furthermore, the engineer will be responsible for post market surveillance inputs to regulatory Technical Documents and support EU MDR certification and re-certification. This position works a hybrid model and will be onsite in Fridley, MN - 3 days per week. Relocation assistance is not provided for this position.
