Senior Technical Document Specialist (Remote)
ArthrexAbout the role
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Technical Document Specialist who is responsible for the preparation of professional use technical documents that are provided electronically, or within finished packaged goods distributed globally covering all Arthrex divisions. These documents follow a 'Style Guide' and are typically referred to as 'Directions for Use’ (DFU), Patient Information Leaflet (PIL), ‘Instructions for Use’ (IFU), Operating Manuals, and ‘SUB DFU’ documents (instructional literature). Members of this team will drive adherence and evolution of Arthrex labeling and DFU policies and procedures necessary to ensure efficient and effective worldwide clearance. In addition, the individuals will support language translation activities which may be required due to the specific geographical market inclusion of Arthrex products. The ideal candidate has a Bachelor's degree, medical device labeling experience, and intermediate knowledge of Component Content Management Systems (CCMS) for content authoring. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
This position is eligible for remote work.
Essential Duties and Responsibilities:
- Manage the creation and maintenance of end-user information / instructional documents.
a. Assist in QMS growth and evolution of all Arthrex DFU guidelines and related work instructions.
b. Provide professional use technical document support for global Arthrex Regulatory Affairs, Engineering, Manufacturing, and distribution sites, outside suppliers, subsidiaries, and Arthrex international points of import.
c. Review and finalize completed informational sections of document formats.
d. Perform readability assessements for layperson facing materials.
e. Create and implement any required formatting modifications to adjust required content into the final formatted DFU artifacts or into other formats, as needed.
f. Prepare output documents for production release using Desktop Publishing software, systems, and techniques, or use of MS Office software, or similar text and graphics file outputs.
g. Coordinate with Arthrex Global Language Management teams with content translation management.
h. Creation, coordination, and monitoring of Engineering Change documents within PLM software (Windchill) tool to obtain release approvals.
- Serve as a point of contact for establishing and maintaining end-user information documents.
- Support the creation and maintenance of end-user information documents.
�� a. Provide administrative support for files and translations which includes translation requests, uploading and downloading files, and confirmation that all language translation projects are complete.
b. Perform in-depth reviews of final format documents for standardization of presentation and graphics, as well as proofing for errors.
c. Coordinate with Arthrex website administrators to maintain the latest release documents on the internet by sending upload requests and files for website upload.
Experience and Education:
High school diploma or equivalent required; Bachelor’s Degree strongly preferred.
5+ years of relevant experience required.
Windchill experience strongly preferred.
Change and release control experience preferred.
Medical device labeling experience preferred.
Experience/training in technical aspects related to desktop publishing software, international translation implementation, and working with Engineering Documentation control systems and processes preferred.
Skills and Knowledge:
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