Position Description:Responsible for the development, evaluation, improvement, and coordination of manufacturing processes required for assembly of mechanical components for Medical Device Finish Good. Design and sustain manufacturing processes, procedures and production layouts for assemblies, equipment installation and qualification, process setup, machining of in-process fixtures or gauges, material handling and End to End value stream mapping. Define optimized sequence of operations, product manufacturability and procedures for the fabrication of tools and equipment and other functions. Implement process validation activities (IQ/OQ/PQ), including protocols, technical justifications, reports, and test methods. Utilize Lean Six sigma methodologies, including GMP (Good manufacturing Practices), Value Stream Mapping (VSM), Design of Experiments (DOE), and statistical analysis (SA). Responsible for Process FMEAs (Failure Mode and Effect Analysis) and support R&D teams in Design FMEAs. Navigate the complexities of government and industry standards including ISO13485, ISO 14971, ISO 9001, US FDA Quality System Regulations 21 CFR 820, EU Medical Device Directive (EU MDD) and EU Medical Device Regulations (EU MDR). Support root cause analysis including Cause/Effect, Fault-tree Analysis, 5S, Statistical Process Control, GR&R, Defect Analysis, and Process Capability studies. Utilize MS Project and MS suite, Product Lifecycle Mgmt. (PLM), Enterprise Resource Planning (ERP) software, statistical data analysis software including Minitab, and design related software including Creo, AutoCAD, and Solidworks. Prepare and present project case proposals using Project/Business acumen methodologies. Lead Process Validation for mechanical assembly devices, injection molding, extrusions, component evaluation/qualification, and mechanical engineering. *Multiple Positions Available. Relocation assistance not available for this position.*Position works a hybrid model and will be onsite in Fort Worth, TX location – 2 days per week.#LI-DNIBasic Qualifications:Masters' degree in Mechanical, Industrial, Manufacturing Engineering or related engineering field and two (2) years of experience as a product or manufacturing engineer or related occupation OR Bachelor's degree in Mechanical, Industrial, Manufacturing Engineering or related engineering field and five (5) years of experience as a product or manufacturing engineer or related occupation. Must possess at minimum 2 years' experience in each of the following: Process validation including IQ/OQ/PQ for mechanical assembly devices, injection molding, extrusions, component evaluation/qualification and mechanical engineering; Lean Six Sigma methodologies, including GMP, VSM, DOE and statistical analysis; Process and Design FMEAs; ISO13485, ISO 14971, ISO 9001, 21 CFR 820, EU MDD, and EU MDR; Root cause analysis to include Cause/Effect, Fault-tree Analysis, 5S, Statistical Process Control, GR&R, Defect Analysis, and Process Capability studies; and PLM, ERP software, Minitab, Creo, AutoCAD, and Solidworks.
