Senior Manufacturing Engineer
Actively Reviewing the ApplicationsInsight Global
Job Description
Required Skills & Experience
3+ years' experience coordinating pilot builds and production readiness activities in a regulated manufacturing environment.
Strong experience with manufacturing data collection, processing, and analysis.
Hands‑on interaction with manufacturing data storage and visualization platforms (e.g., Illuminator or similar systems).
Bachelor’s degree in Engineering (Manufacturing, Industrial, Mechanical, Chemical, or related).
Experience in medical device manufacturing or similarly regulated industries
Strong understanding of GMPs, validation principles, and data integrity requirements
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 statistical analyses; establish process capability metrics (Cp/Cpk, Pp/Ppk).
-Define and implement process control limits, control plans, and monitoring strategies using manufacturing data systems.
-Lead Measurement System Analysis (MSA) and Gage R&R activities to ensure data integrity and measurement reliability.
-Provide hands‑on manufacturing support during development, qualification, validation, and production stabilization.
-Author and execute protocols and audit‑ready completion reports in support of process validation and regulatory inspections.
-Support validation and troubleshooting of PLC‑controlled manufacturing systems in collaboration with automation and controls teams.
Required Skills
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