R&D Technical Writer

This range is provided by Ledgent Technology. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$33.33/hr - $43.33/hr

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Our leading medical technology client is seeking an R&D Technical Writer to support a variety of content development and labeling initiatives for R&D and manufacturing defibrillators.

• Produce clear, concise, and understandable technical documentation that meets the needs of different user groups, from general users to healthcare professionals.
• Develop content (online and written) for a variety of complex medical devices, collaborating cross-functionally to provide accurate information that is compliant with FDA, MDR, and additional requirements.
• Creating, updating, and maintaining product documentation and labeling assets for both new product development and sustaining engineering projects.
• Participate in NPD and sustaining product meetings to provide insights on best quality outcomes for instructional material strategies and resolve related challenges.
• Coordinating translation packets to ensure timely and accurate localization of materials. Support translation efforts to enable global product reach.
• Oversee and provide recommendations for the development of formats and guidelines for documentation.
• Ensure effective planning and management of timelines for all aspects of technical documents.
• Develop, write, edit, and revise product documentation including Operating Instructions, Technical Manuals, Setup Guides, and Instructions for Use (IFUs) that provide instructions and information detailing user/patient safety, product features, procedures for handling, maintenance, etc.
• Organize content and complete writing assignments according to established guidelines for order, content, clarity, conciseness, format, style, and terminology.
• Conceptualize graphical elements (tables, charts, illustrations, etc.) that support instructional information.
• Collaborate with label/marking designers to align labeling and product documentation content and assist with product label updates using Adobe Illustrator.
• Utilize change management systems for product deliverable releases/updates.
• Help establish standardized text, glossaries and nomenclature, style guides and templates, and structure of instructional information.

• Bachelor's degree in engineering, business, technical writing, or related discipline
• 2+ years of experience in a medical device, pharmaceutical, or similarly regulated environment preferred
• Adobe In Design and Illustrator expertise required
• Product label design and updates experience preferred
• Jira and Windchill experience preferred
• Working knowledge of FDA and MDR labeling requirements preferred
• Knowledge of printing and graphic reproduction practices preferred
• Knowledge of XML authoring tools and XML publishing using CSS preferred
• Knowledge of a variety of writing formats including print, web, and multimedia desired
• Self-directed contributor - take ownership of work and need no prompting to drive productivity, change, and outcomes.
• Collaborative partner - build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• Dedicated achiever - thrives in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.

For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

Mid-Senior level

Full-time

Engineering and Writing/Editing

Biotechnology Research and Engineering Services