Manufacturing Engineer II

Job description

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 initiat...