Technical Writer - Engineering

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The Engineering Department is seeking a Technical Writer who will be responsible for developing, writing, and editing technical documentation, such as Standard Operating Procedures, Verification and Validation Plans, Test Protocols and Reports, Engineering Change Orders (ECO), Traceability Matrix’, Risk Management File, and populating Project Design and Development Design History Files (DHF) that conform to Arthrex’ Quality Management System Requirements. This position will be located at our Naples, FL campus. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Researches, gathers, and organizes source information from Subject Matter Experts (SME) to write and revise technical documentation
• Process project design and development technical documentation that is compliant to Arthrex Quality Management System (QMS) standards
• Process Engineering Change Orders (ECO) related activities in all applicable Arthrex’s software
• Administer Project DHF document structure, integrity and placement in Arthrex’s applicable software
• Ensures that all document submissions for cross functional stake holder review are technically accurate, consistent with QMS format and content guidelines in regard to clarity, flow, organization, completeness, accuracy, readability and/or appropriateness
• Provide internal customer guidance and support for all process, document, and record related activities associated with the department
• Act as liaison between Engineering and various cross functional stake holders to assist in efforts to further automate Engineering Documentation
• Provide support to GmbH Engineering when required to help create compliant document submissions
• Develops and manages product compliance initiatives to relevant standards governing Medical Electrical Equipment
• Proactively identify and propose opportunities for improvement in daily workflow
• Miscellaneous documentation tasks as assigned

Education and Experience:

• Associates Degree or 3 years of direct experience in Document Control (including engineering change management) required
• Technical writing experience required
• Strong interpersonal, oral, and written communication skills required
• Experience in Agile, Documentum, SAP, or any other relevant software preferred
• Experience or formal training in technical aspects of Engineering Documentation/Record Control preferred
• Experience in regulated industry preferred

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Understanding of ISO, FDA, and other relevant requirements as related to control of documents and records, to ensure compliance with such requirements and efficiency in related business processes
• Understanding of Engineering requirements, and Quality Assurance fundamentals
• Detail-oriented, ability to learn and follow procedures and processes accurately, and ability to work in fast paced environment and handle multiple tasks and requests

Machine, Tools, and/or Equipment Skills:

Advanced software skills: Word/ Excel/ Power Point, research tools, internet search tools. Light understanding of CAD design software.

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