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Technical Writer
Technical WriterA-Line Staffing Solutions LLC • San Diego, CA, US
Technical Writer

Technical Writer

A-Line Staffing Solutions LLC • San Diego, CA, US
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Title : Technical Writer

Location : San Diego, CA

Note : This is a W2 contract role – 1099, C2C, & 3 rd party candidates WILL NOT be considered

The Technical Writer will be responsible for developing writing and maintaining comprehensive technical documentation for Class II medical devices. This role requires a detail-oriented professional with strong writing skills and a deep understanding of regulatory requirements. Ideal candidates for this role will have extensive experience in the medical device industry and the ability to work effectively with cross-functional teams.

Position Responsibilities :

  • Create, edit, and maintain customer and internal facing technical documentation, including user manuals, installation guides, troubleshooting guides, and upgrade / downgrade instructions for various country regulatory submissions
  • Ensure all documentation meets regulatory requirements, industry standards, and company policies
  • Create illustrations, flow charts, diagrams, and line art, in addition to product photos for both quality and technical documentation
  • Provide recommendations to engineers on optimizing engineering data expressed in graphs, illustrations, and tables to ensure clarity and consistency
  • Collaborate with engineering, quality assurance, regulatory affairs, clinical / medical affairs, marketing, customer support, and other departments to gather information and ensure accuracy and completeness of documentation, and to suggest changes to enhance a document's readability, clarity, conciseness, and style
  • Collaborate with Subject Matter Experts in the review and development of instructions-for-use IFU design specifications, as part of the product’s quality documentation
  • Review and edit technical documents for clarity, accuracy, and compliance
  • Develop and implement documentation standards, best practices, and style guides to ensure consistency and quality
  • Communicate effectively with all levels of management, business units, corporate, and international, and possesses a high degree of flexibility / selectivity in prioritizing business unit deliverables to meet company goals
  • Stay current with industry trends, regulatory changes, and best practices in technical writing and medical device documentation
  • Provide guidance and mentorship to junior technical writers and other team members
  • Manage fast-moving documentation projects, including timelines, resources, and deliverables
  • Participate in conduct and drive cross-functional team meetings to provide input on documentation requirements and timelines

Position Qualifications :

  • 5+ years of Technical Writing experience, writing and editing hardware / software user guides, print and online, and other technical product documentation, including experience working in a highly regulated industry, such as medical devices or pharmaceuticals
  • Extensive experience with regulatory compliance processes, including a strong background in supporting regulatory requirements to ensure adherence to regulatory guidelines
  • Experience with SAP Oracle or similar enterprise resource planning ERP system
  • Experience in Version Control Systems (VCS), such as Perforce, Apache Subversion, Microsoft Team Foundation Server, or GitHub
  • Knowledge of photography and photo editing software, such as Adobe Photoshop
  • Skilled in both electronic and hard copy markup
  • Experience with Acrobat tracked changes in Microsoft Word, including standard editorial and proofreading symbols
  • Knowledge and experience with desktop publishing (DTP) software applications, such as MadCap Flare, Adobe FrameMaker, Adobe InDesign, Adobe Illustrator, or XML DITA, as applicable for technical documentation
  • Familiarity with electro-mechanical concepts and software application usage
  • Experience in device labeling and / or packaging content development
  • Familiarity with large company engineering, change control processes, and Agile software development methodologies
  • Ability to work under compressed deadlines and deal with unresolved situations, frequent project changes, delays, or other events
  • Ability to effectively manage the delivery of prioritized tasks
  • Ability to handle multiple projects with excellent follow-up and project management skills
  • Ability to demonstrate a high level of initiative to gather information for developing documentation
  • Ability to work independently with minimal supervision
  • Effective independent thinking and problem-solving skills with product core team members
  • Ability to work collaboratively with marketing, clinical, quality, and regulatory reviewers
  • A minimum of a Bachelor's Degree in Information Technology, Business, Marketing, or other related field preferred
  • Note : This is a W2 contract role – 1099, C2C, & 3rd party candidates WILL NOT be considered

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