Job Description
An employer is seeking Senior Manufacturing Engineer with a strong focus on manufacturing data collection, pilot execution, and process control to support medical device production in the Blue Ash, OH area. This role bridges manufacturing execution with data systems to enable robust process monitoring, capability analysis, and continuous improvement. The ideal candidate excels in pilot build coordination, manufacturing data systems, and translating production data into actionable insights that support compliance, efficiency, and scalability.

Core responsibilities will include:
-Support New Product Development (NPD) and manufacturing scale‑up in compliance with FDA, ISO 13485, and internal quality systems.
-Plan and execute engineering and pilot builds, coordinating cross‑functionally to transition processes into full production.
-Develop and execute process characterization plans to identify and optimize CPPs and CQAs.
-Design and execute DOE and...