Staff Technical Writer

The Staff Technical Writer is responsible for managing the publication and translation of product labeling for Cepheid’s Xpert tests and GeneXpert instrument systems. The associate will have an opportunity to partner with Regulatory Affairs and collaborate with cross-functional teams (e.g., Product Transfer, R&D, Hardware/Software Engineers, Clinical) to create, edit, format, and publish primary labeling (e.g., Instructions for Use (IFUs), Quick Reference Instructions (QRIs), Operator’s Manuals/User’s Guide, and Getting Started Guides) for Cepheid’s menu of in vitro diagnostic products. 

This is an on-site position within the Technical Publications team structured under Cepheid’s Regulatory Affairs – New Product Development group located in Sunnyvale, CA. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions. 

In this role, you will have the opportunity to: 

• Lead and manage a functional team and projects to solve complex problems and identify innovative solutions, collaborating with subject matter experts (SMEs) and cross-functional teams to gather, verify, and validate technical information, ensuring all documentation is complete and accurate. 

• Develop, edit, and publish clear, accurate Instructions for Use (IFUs), Quick Reference Instructions, and other regulatory-compliant documents for Cepheid’s Xpert tests. 

• Manage the end-to-end creation of documentation, including operator’s manuals, user guides, getting started guides, and service manuals for Cepheid’s instrument systems. 

• Drive quality and consistency by reviewing and peer-reviewing publications for content accuracy, format, and adherence to Cepheid’s style guide. Monitors and enforces content reuse policies and develops DITA style guides use in online user documents and be able to modify DITA cascading Style sheets.  

• Coordinate translation requests with external suppliers, format post-translation documents, and manage the release of final documentation in Cepheid’s system. 

The essential requirements of the job include: 

• Bachelor’s degree in Life Sciences with 8+ years of technical writing experience in the biotech industry OR Master’s degree in field with 6+ years of related work experience 

• Proficiency in XML/DITA CCMS, Adobe FrameMaker, Acrobat, Illustrator, Photoshop, InDesign, Microsoft Word, and ABBYY FineReader; experience developing DITA styling for online documentation. 

• Strong command of English grammar, punctuation, and writing, with attention to detail, accuracy, and adherence to policies, procedures, and style guides. 

• Experience participating in product development teams, creating and updating SOPs, and conducting verification and validation of technical publications. 

• Excellent organizational and communication skills with the ability to prioritize, multi-task, and work with focused urgency as required by project timelines. 

It would be a plus if you also possess previous experience in: 

• Proficiency in preparing images for technical documentation and have in-depth knowledge as a CMS Administrator 

• Experience in medical equipment writing and familiarity with Agile documentation systems.