Title: Technical Writer

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 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. The ideal candidate 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 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
• 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)
• Knowledge and experience with desktop publishing (DTP) software applications (MadCap Flare, Adobe FrameMaker, Adobe InDesign, Adobe Illustrator, XML, DITA), as applicable for technical documentation
• 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