The Engineering Documentation Specialist will assist engineering with development and maintenance of all documentation required to support new product introduction and manufacturing for a fast-growing medical device startup company. The successful candidate will be comfortable working with engineers and quality assurance to transfer technical information into easy to understand written form, as well as take a hands-on approach to learning and documenting the processes.
Maintain accurate product configuration in an Excel file as an easy-to-read reference used during Design Verification testing.
Modify / create procedures (MPI’s, WI’s) for manufacturing, testing and field service activities.
Prepare and submit documentation changes per the Change Order approval process in PLM system (Arena).
Work with engineers to update purchasing specifications, create memos to file, and other engineering documents as needed.
Create / update Item Masters, BOM’s, routers and other MRP inputs.
Create assembly training aids through pictures, video and physical samples.
Perform audits of manufacturing records during assembly to ensure compliance.
May assist with processing calibration records, non-conforming reports (NCR’s) and supplier corrective action reports (SCAR’s).
May perform final manufacturing Device History Record (DHR) review at close of manufacturing process.
Support engineering with other documentation related tasks as required.
High School degree or equivalent required.
2+ years’ experience working in a compliance-oriented manufacturing environment and work with FDA 820 and ISO 13485 preferred.
Experience creating / modifying manufacturing process instructions.
Experience with Electronic Change Request/PLM systems and Arena preferred.
Experience with MRP systems, working with Item Masters and QAD preferred.
Strong computer skills including Microsoft Word, Excel, Visio and PowerPoint.
Preferred skills include creating flowcharts in Visio, manipulating data in Excel utilizing vlookups and pivot tables.
Very high level of attention to detail and accuracy.
Excellent verbal and written communication skills.