Technical Writer

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