Sr. Manufacturing Engineer

Insight Global • Blue Ash, OH • 2h ago

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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

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

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