Required Skills & Experience Bachelor's degree in Mechanical Engineering with 5+ years of industry experience Strong understanding of Geometric Dimensioning & Tolerancing (GD&T) Proficient in SolidWorks for 3D CAD modeling, design analysis, and creating detailed mechanical drawings Hands-on manufacturing experience Nice to Have Skills & Experience Experience with assembly processes, including machining, injection molding, optics, motion systems, and fluidics. Familiarity with GMP/GDP standards Job Description Lead and support mechanical engineering efforts for NPI, covering design development, verification, validation, and production transfer Design and development of manufacturing test fixtures as required. Design fixtures and tooling to help reduce cost of machine setup and reduce scrap Teaming with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes, implement mitigations, and leverage risk based decision making Create process requirements for both informing design activities, and to implement equipment and fixturing needed for process development and manufacturing efforts Develop and maintain documentation for design and process control, product configurations, manufacturing procedures, (e.g., travelers, bills-of-materials, Work Instructions, Lot History Records), and other Quality System requirements Evaluate existing engineering processes and implement process improvements Using Lean principles, Lead and/or actively participate in product/process engineering problem solving Identify opportunities and implement changes to improve products and reduce costs by using knowledge of assembly methods, quality control standards, fabrication processes, tooling, production equipment, product design, and materials Support the transfer of product lines and the qualification-validation efforts Prepare reports and presentations summarizing information or trends related to manufacturing performance Provide technical expertise or support related to manufacturing