ManufacturingEngineerII

## Role Overview As a Manufacturing Engineer II, you will contribute to developing and improving manufacturing processes for orthopedic medical devices. You will execute validation activities, support new product introductions, and drive continuous improvement within a regulated manufacturing environment. In this role, you will develop technical depth in manufacturing while supporting larger projects and cross-functional initiatives. ## Responsibilities * Develop, implement, and sustain manufacturing methods, process documentation, and operating procedures for assigned product lines. * Support new equipment installations and validation activities, including: User Requirement Specifications (URS), Functional Design Specifications (FDS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Risk Assessment (VRA). * Conduct process troubleshooting and data analysis to improve yield, reduce variation, and prevent recurrence of non-conformances. * Partner with cross-functional teams (Quality, NPD, Operations, and Maintenance) to optimize manufacturability and compliance. * Support continuous improvement and lead cost-reduction initiatives. * Develop and maintain process documentation including work instructions, routers, and validation reports. * Assist in developing Process Maps, pFMEAs, MSA plans, and control plans for process risk analysis. * Contribute to the introduction and transfer of new products or processes into manufacturing. * Perform other duties as assigned by the Manufacturing Engineering Manager or Senior Engineer. ## Education • Bachelor of Science in Engineering required • Master of Science in Engineering desired ## Experience * 2–4 years of manufacturing engineering experience in a regulated industry; medical device preferred. * Experience with CNC machining, metal finishing (e.g., bead blast, grit blast, polishing), or additive manufacturing preferred. * Familiarity with validation activities (