Manufacturing Documentation & Systems Specialist

Cook Medical Inc.; Bloomington (IN); On-site; USD 65,000 - 85,000; Full time

Job summary

Cook Medical Inc. in Bloomington, IN seeks a Manufacturing Engineering Specialist focused on Documentation to support operations, equipment procurement, testing, and training. You will develop and maintain documents, procedures, and manufacturing instructions ensuring alignment with quality and regulatory requirements.

You will collaborate across functions to drive continuous improvement, implement changes in AgilePLM, and mentor teammates while upholding FDA 21 CFR 820 and ISO 13485 standards.

Qualifications

• AS or BS degree in a relevant field or equivalent experience.
• Experience working independently with minimal supervision.
• Proficiency with Microsoft Office (Word, Excel) and AgilePLM.

Responsibilities

• Independently produce, organize, and maintain documentation or systems critical to the engineering team.
• Support short- and long-term projects or significant tasks for Cook, Inc. projects.
• Install and qualify equipment in production areas.
• Develop or revise documents and procedures (Drawings, Work Instructions, SOPs).
• Prepare prototype work orders and manufacturing documentation; perform testing related to manufacturing projects.
• Drive creation and implementation of priority change orders within AgilePLM.
• Troubleshoot documentation issues and systems as needed.
• Mentor and train team members; identify areas for improvement.

Education

AS or BS degree in relevant field

Tools

AgilePLM

Microsoft Office

Job description

Cook Medical Inc. in Bloomington, IN seeks a Manufacturing Engineering Specialist focused on Documentation to support operations, equipment procurement, testing, and training. You will develop and maintain documents, procedures, and manufacturing instructions ensuring alignment with quality and regulatory requirements.

You will collaborate across functions to drive continuous improvement, implement changes in AgilePLM, and mentor teammates while upholding FDA 21 CFR 820 and ISO 13485 standards.