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:

Able to create, modify and maintain instructional assets.

Able to create and modify SUB DFUs.

Able to upload approved DFUs to the Arthrex eDFU platform and appropriately manage language-specific versions.

Able to delegate projects while serving as the point of contact for the DFU team for specified projects.

Able to facilitate on-the-job training of new DFU team members.

Able to initiate and coordinate process improvement suggestions.

Able to coordinate activities related to obtaining translations of English master content.

Prepare output documents for final publication using Desktop Publishing software and techniques, or MS Office software, or similar text and graphics file manipulation to result in publication-ready documents.

Generate engineering change request documentation to support engineering product development and Regulatory Affairs activities through the engineering PLM approval process

Serve as point of contact for establishing and maintaining end-user information documents.

Effective written and verbal communication skills.

Proficiency in MS Office required.

Reasoning Ability:

            Ability to define problems, collects data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills:

            Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

 Language and Communication Skills:

            Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.  Ability to verbally communicate ideas and issues effectively to other team members and management.  Ability to write and record data and information as required by procedures.

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Gym Reimbursement Program
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.