Engineering Documentation Specialist

Description

Position Summary:

Responsible for development, support, and change control of assembly procedures and related documentation for products and devices manufactured at bioMérieux, St. Louis. Creates, edits, and distributes various documentation in support of manufacturing processes.

Primary Responsibilities:

• Participate in project planning activities, and estimating timelines for documentation development and production.
• Use design control and associated change management systems and other change processes as defined by Company procedures and the FDA Quality Systems Regulations.
• Research, write and format assembly documentation consisting of hardware assembly and test methods according to departmental styles and standards. Proofread documentation for accuracy and adherence to standards.
• Generate and maintain track all electronic and hard-copy controlled documents in accordance with company policies and regulatory agency (e.g., FDA and ISO) requirements.
• Compile reports, spreadsheets, and documentation as needed to support departmental workflow. Communicate with internal review teams to obtain approvals necessary for product/procedure release.
• Create and maintain Assembly Procedure Files and associated design documentation. Archive and organize hard copies and electronic copies of documentation and graphics.
• Track and implement change requests, errors, issues, and requirements logged against Assembly documentation.
• Responsible for the generation of IRC refurbishment procedures working closely with the IRC team to develop and maintain formats and styles.
• Responsible for consolidating and reconciling all comments and inputs from production personnel, Engineering and others and incorporating these inputs into the appropriate documentation.
• Regularly interface with other department personnel to ensure that parts concerns are reconciled.

Education, Skills, & Experience:

• Associates Degree plus two (2) years of relevant experience (industrial medical experience or technical publications experience) is preferred. Will consider a combination of education and/or experience.
  • High School Diploma/GED with Four (4) years of relevant technical publication experience also accepted
• Experience with Adobe InDesign, FrameMaker, Illustrator, and Photoshop strongly preferred.
• Proficiency in Microsoft Office Suite is required.
• Experience with SolidWorks Composer is a plus.
• Excellent written and oral communication skills, as well as strong organizational skills are essential.
• Exceptional attention to detail and self-starter.