Technical Writer II

This position will provide technical writing support for instrument and software operator manuals, service manuals, and technical bulletins. As a member of the R&D Instruments group, this position will take in technical information from multiple cross-functional groups to develop instrumentation manuals (operators manuals, service manuals), and technical bulletins. Primary Responsibilities for Role • Revise and edit legacy product documentation as required, including but not limited to, operator manuals, service manuals, and technical bulletins. • Manage translation projects with the translation vendor and perform translation reviews for consistency with formatting and layout. • Effectively manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met. • Process documents through the electronic documentation control system (LSQM). • Manage all aspects of document development and assist in production release, including draft reviews. • Maintain accurate version control, change history, and traceability for all deliverables. • Ensure that documentation is accurate, complete, meets specifications, and adheres to standards for quality and style. • Ensure compliance of labeling with all applicable regulatory/QSR requirements. • Create and edit documentation in compliance with requirements from applicable regulatory bodies (FDA, IVDR, EUDR) and the European Union (EU Medical Device Regulation). • Collaborate with departmental and cross-functional peers to ensure proper resolution to questions and issues during the document development process. • Continually review the document development process to ensure quality in labeling output. Additional Responsibilities • Keep track of documentation through the entire development process while adhering to time lines, maintaining revision control, maintaining change lists, and managing reviews • Ensure that documentation is accurate, complete, meets specifications, and adheres to standards for quality and style. Knowledge, Skills, and Abilities • Advanced writing/editing skills • Self-directed and highly organized • Ability to manage multiple priorities • Excellent communication skills • Cross-functional, collaborative nature • Proven ability to work with global stakeholders • Experienced maintaining accurate change lists, content change control, and file version control throughout the documentation development process. • Familiar with best practices regarding topic-based authoring, content reuse, conditional text, and variables. • Medical terminology experience • Proficient with Microsoft 365 applications, SharePoint, Adobe FrameMaker, and Adobe Acrobat Pro. • Experienced using Visio and SnagIt Editor or similar applications to create diagrams, illustrations, flow charts, and screenshots. • Experienced using Confluence, Jira, or similar collaboration and tracking tools. • Hands-on experience with instrumentation and software • Familiar with best practices regarding topic-based authoring, content reuse, conditional text, and variables. Education • Bachelor's degree, preferably in English or Technical Communication, similar related fields. Experience • Minimum five years of experience writing end-user software or hardware instructions. • Experience in the medical device industry preferred • Experience working in a federally regulated environment (FDA/UMDR) The estimated pay scale for Technicial Writer II role based in California, is $90,000 - $110,000 per year. Additionally, the position is eligible to participate in up to 8%of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg