Product Engineer

Position Description:

Product Engineer for Medtronic, Inc. located in Fridley, MN. Responsible for evaluating, improving and controlling the performance of external neuromodulation devices that are repaired and returned to the field. Review and analyze complaint data and perform service monitoring activities to pinpoint and prevent potential product performance issues before they arise. Author and execute Test Method Validations for inspecting and testing the precision and accuracy of New Product Introductions (NPI). Responsible for Complaint Handling, Service Monitoring, and Audit. Coordinate test methods, equipment and tooling validation. Identify and investigate non-conformances and gaps in processes; utilize lean manufacturing Root cause analysis and problem solving methods including DMAIC; develop and implement Corrective and Preventative action (CAPA) plans; update Process failure Mode and Effects Analysis (PFMEA); Responsible for equipment and process validations including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) and process changes. Apply various engineering concepts involving validation, Geometric Dimension & Tolerancing (GD&T), Gage Repeatability and Reproducibility (Gage R&R) and other Measurement System Analysis (MSA) and statistical analysis. Leverage analytical and system tools including Minitab. Leverage Manufacturing Execution Systems (MES), Enovia, Trackwise and Agile Quality Mgmt. System (QMS). Responsible for ensuring that Current Good Manufacturing Practices (cGMPs), Current Good Documentation Practices (cGDPs), FDA Quality System Regulations (QSRs), customer requirements, and internal policies and procedures are adhered to for quality outcomes. Navigate the complexities of various government and industry regulations to include FDA 21 CFR Parts 11, 210, and 820, and ISO 9001, ISO 13485 and ISO 14971 standards.

Basic Qualifications:

Master’s degree in Mechanical, Industrial or Biomedical engineering or related engineering field and 6 months experience as a product or quality engineer in the medical device industry; Or, Bachelor’s degree in Mechanical, Industrial or Biomedical engineering or related engineering field and 2 years’ experience as a product or quality engineer in the medical device industry. Must possess at least 6 months experience with each of the following: Medical device Complaint Handling, Service Monitoring, and Audit; Test Method, Equipment and Tooling Validation; DMAIC, Root Cause Analysis, CAPA and PFMEA; IQ/OQ/PQ and process changes; GD&T, Gage R&R, MSA, statistical analysis, and Minitab; MES, Enovia, Trackwise, and Agile QMS; cGMPs, cGDPs, and FDA QSR; FDA 21 CFR Parts 11, 210, 820, and ISO 9001, ISO 13485 and ISO 14971

Relocation assistance not available for this position.

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