Manufacturing Engineering Specialist, Documentation

Cook Group•Bloomington, IN

About The Position

A Manufacturing Specialist provides direct technical support to operations in documentation, equipment procurement, testing, operational excellence, and training. The role collaborates with multiple company functions to help ensure equipment and production systems operate safely and with a focus on quality. The specialist independently maintains engineering-team documentation and systems, supports projects, installs and qualifies production equipment, and develops or revises manufacturing documents and procedures. The role also mentors and trains colleagues, troubleshoots issues, and identifies opportunities for improvement while adhering to applicable quality and regulatory requirements.

Requirements

Associate or bachelor's degree in a relevant field, or experience of a kind and amount that provides a comparable background.
Experience working independently and with minimal supervision.
Working knowledge of Microsoft Office software, such as Word and Excel, and AgilePLM.
Ability to read and follow product and packaging specifications, manufacturing instructions, and drawings.
Ability to meet the position’s training requirements and applicable quality and regulatory requirements.

Responsibilities

Independently produce, organize, and maintain documentation or systems critical to the engineering team or department.
Support short-term, long-term, and system-focused projects, and complete significant tasks critical to company projects.
Install and qualify equipment in production areas.
Develop or revise drawings, work instructions, standard operating procedures, and other documents.
Prepare prototype work orders, develop manufacturing documentation, and perform testing associated with manufacturing projects.
Drive the creation and implementation of priority change orders within AgilePLM.
Support documentation across multiple projects simultaneously.
Troubleshoot systems and documentation issues as needed.
Use judgment and experience to independently accomplish project objectives.
Maintain strong knowledge of the team’s focus and relevant company systems, including jBase, AgilePLM, and Opcenter.
Serve as a mentor, trainer, and resource to the team within the area of expertise.
Identify areas for improvement and offer solutions.
Prioritize work based on assigned goals.
Read, comprehend, and follow product and packaging specifications, manufacturing instructions, and drawings.
Maintain position training requirements and seek opportunities for continuous development and growth.
Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.