Job description

Job Title: Lead Analyst, R&D Technical Writing 6 month contract On-site in Fremont, CA Must be able to work on a W2 Job Summary: The Lead Analyst, R&D Technical Writing will support Sustaining R&D by creating end-user, regulatory-compliant product labeling and documentation. This role contributes to new product development and design change initiatives by developing label artwork, improving documentation processes, and ensuring compliance with regulatory and quality standards. The Lead Analyst will collaborate cross-functionally, manage multiple labeling projects, and lead continuous improvement efforts across labeling and documentation functions. Job Responsibilities: • Develop and release compliant end-user product labeling and associated artwork/images for new and existing medical devices. • Lead or support continuous improvement initiatives (NCs, CAPAs) and documentation quality plans. • Conduct research to ensure technical accuracy and reader comprehension in all deliverables. • Create and maintain SOPs, work instructions, technical literature, and other controlled documents following Good Documentation Practices (GDP). • Provide weekly activity summaries, maintain project plans, and communicate status updates to internal customers. • Lead compliance projects (e.g., recertification), working with stakeholders to ensure timely and quality outcomes. • Support internal and external audits by preparing documentation, participating in front-room discussions, and maintaining audit-readiness. • Modify or develop new Quality System documentation (e.g., SOPs, forms, checklists) with minimal supervision. • Provide training content and assist in the communication of new or revised procedures. • Ensure all deliverables meet applicable standards and style guidelines while maintaining a high level of accuracy and detail. Job Qualifications: • Bachelor’s degree in Graphics, Language, or a related field; or equivalent experience (Advanced degree may be considered toward years of experience). • 4–6 years of relevant experience in technical writing, labeling, or documentation within regulated industries. • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Visio). • Proficient in Adobe Suite (InDesign, FrameMaker, Photoshop, Illustrator). • Experience with database-driven labeling systems (e.g., Prisym ID, Label View, Loftware, Bartender, NiceLabel, EasyLabel). • Knowledge of web design and testing is preferred. • Strong attention to detail and ability to review/audit documentation for accuracy and compliance. • Demonstrated success managing multiple high-priority tasks in a fast-paced, deadline-driven environment. • Experience leading structured problem-solving and process improvement initiatives. • Familiarity with quality system documentation and regulatory compliance in a life sciences or medical device environment.

Requirements