Manufacturing Engineering Specialist, Documentation

Cook Group • Bloomington, IN

4d

About The Position

A Manufacturing Specialist provides direct technical support to operations in documentation, equipment procurement, testing, operational excellence, and training. The role works collaboratively across company functions to help ensure equipment and associated production systems operate safely and with a focus on quality.

The position independently creates and maintains engineering documentation and systems, supports projects, installs and qualifies production equipment, prepares manufacturing documentation, and performs related testing. It also involves troubleshooting, mentoring and training teammates, identifying improvements, prioritizing work, and maintaining knowledge of relevant team systems. The role must follow the Quality Management System and applicable regulatory requirements, including FDA 21 CFR 820 and ISO 13485.

Requirements

• Associate of Science or Bachelor of Science degree in a relevant field, or comparable experience providing a similar background.
• Experience working independently and with minimal supervision.
• Working knowledge of Microsoft Office software, such as Word and Excel, and AgilePLM.

Responsibilities

• Independently produce, organize, and maintain documentation or systems critical to the engineering team or department.
• Support short- and long-term projects, system-focused projects, and 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 and procedures.
• 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 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 all training requirements while pursuing 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.

What This Job Offers

• Job Type: Full-time
• Education Level: Associate degree