Full Job Description
Owns creation, execution, and maintenance of technical documentation for New Product Development and other projects. This role collaborates with various functions to understand, develop, and maintain all aspects of technical documentation across projects.
Develop (research/write/illustrate) content, including understanding and communicating detailed technical concepts
Work closely with R&D Engineering, Regulatory, Quality, and Marketing to create any new project-related technical documentation and to make ongoing updates that are a result of user feedback, review of risk management file, and to support regulatory and quality compliance.
Responsibilities:
Produces technical documentation including user manuals, package inserts, and other technical guides.
Analyzes and updates existing and new documents to maintain continuity with regulations and project needs.
Designs labels based on input from cross-functional team.
Confers with project managers, engineers, and regulatory experts to establish technical specification, determine text and illustrations to be developed for publication, and ensure accuracy of product documentation.
Determines technical documentation priorities based on timelines and resource capacity.
Anticipates potential project problems and creates solutions or contingency plans.
Manages workload across multiple projects.
Qualifications:
Bachelor's Degree in Engineering, English, Technical Writing, Communications, or related work experience.
Experience Requirements:
5+ years technical writing experience.
2+ years in regulated industry preferred.
High-tech, medical device labeling and documentation development experience preferred.
Proficiency in Microsoft Office required, and Adobe Creative Suite (InDesign, Acrobat Pro and Illustrator) preferred.
Other Qualifications, Skills & Certifications:
Self-starter
Detail oriented
Excellent written and spoken communication
Able to work cross-functionally with project team members
Able to multi-task across many concurrent projects
Willingness to work outside of typical job duties to support the team
Medical device experience (Preferred)