Job Description
Job Description
Title: Technical Writer
Pay Rate: $48.51/hr
Location: San Diego, CA
Note: This is a W2 contract role – C2C & 3rd party candidates WILL NOT be considered
The Technical Writer will be responsible for working with Engineers, Product Managers, and other Subject Matter Experts in the development of technical product and process support 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, the ability to work effectively with cross-functional teams, and must demonstrate a strong, foundational understanding of technical product support documentation.
Position Responsibilities:
• Create, edit, and maintain customer and internal facing technical documentation, including user manuals, installation guides, troubleshooting guide, 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
• 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 and editing experience for hardware/software user guides (print and online) and other technical product documentation
• Experience working in a regulated industry, such as medical devices or pharmaceuticals, with extensive regulatory compliance process experience; strong background in supporting regulatory requirements to ensure adherence to regulatory guidelines
• Knowledge and experience with desktop publishing (DTP) software applications (MadCap Flare, Adobe FrameMaker, Adobe InDesign, Adobe Illustrator, XML, DITA), as applicable for technical documentation
• Experience with end-user documentation (IFUs, customer-facing manuals and guides)
• 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
• 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
• Skill in both electronic and hard copy markup (Acrobat, tracked changes in Microsoft Word, standard editorial and proofreading symbols)
• Demonstrated ability to be highly collaborative with marketing, clinical, quality, and regulatory reviewers
• Ability to communicate effectively with all levels of management and business units (corporate and international)
• A high degree of flexibility/selectivity in prioritizing and managing business unit deliverables to meet company goals
• Ability to demonstrate a high level of initiative to gather information for developing documentation
• Ability to work independently with minimal supervision
• Effective independent problem-solving skills with product core team members
• Ability to work under compressed deadlines and deal with unresolved situations, frequent project changes, delays, or other events
• Ability to handle multiple projects with excellent follow-up and project management skills
• Experience with SAP, Oracle, or similar enterprise resource planning (ERP) systems preferred
• Bachelor's Degree in Information Technology, Business, Marketing, or other related field preferred
Note: This is a W2 contract role – C2C & 3rd party candidates WILL NOT be considered