Manufacturing Engineer II

Role: Manufacturing Engineer II focused on ocular product manufacturing, including scale-up, development, and sustaining activities. Responsibilities: develop and optimize manufacturing processes, support new product introductions, design and validate equipment, tools, and fixtures, generate CAD models/drawings, write protocols and reports, ensure compliance with GMP, FDA (21 CFR), and ISO standards, and lead manufacturing projects with cross-functional teams. Requirements: BS in Mechanical Engineering or related field; 2+ years medical device/pharma experience; experience with complex manufacturing methods and tooling design (Solidworks preferred); knowledge of cGMP, ISO standards, and manufacturing validation. HighValue: ocular products, medical device manufacturing, process validation, design for manufacturability, GMP compliance, cross-department collaboration. WorkSetup: not specified; likely on-site given cleanroom and manufacturing focus.