Technical Writer

ZipRecruiter; San Diego (CA); Remote; USD 70,000 - 100,000; Full time

Job summary

A leading company is seeking a Technical Writer for a W2 contract role, focusing on developing and maintaining technical documentation for Class II medical devices. The ideal candidate will possess strong writing skills and extensive experience in the medical device industry, ensuring compliance with regulatory standards. Responsibilities include creating user manuals, collaborating with engineering teams, and managing documentation projects. This remote position requires a detail-oriented professional capable of working independently and under tight deadlines.

Qualifications

• 5+ years of technical writing and editing experience.
• Experience in regulated industries like medical devices.
• Familiarity with electro-mechanical concepts.

Responsibilities

• Develop and maintain technical documentation for medical devices.
• Collaborate with cross-functional teams to gather information.
• Ensure documentation meets regulatory requirements.

Skills

Technical Writing

Regulatory Compliance

Collaboration

Problem-Solving

Education

Bachelor's Degree in Information Technology

Bachelor's Degree in Business

Bachelor's Degree in Marketing

Tools

Adobe Photoshop

MadCap Flare

Adobe FrameMaker

Adobe InDesign

GitHub

SAP

Oracle

Job description

Job DescriptionJob Description

Title: Technical Writer

Location: Work from Home

Note: This is a W2 contract role – C2C & 3rdparty 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 andmentorshipto junior technical writers and other team members
• Manage fast-moving documentation projects, includingtimelines, resources, anddeliverables
• Participate in, conduct, and drive cross-functional team meetings to provide input on documentation requirements andtimelines

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 withelectro-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, orGitHub
• Knowledge of photography and photo editing software, such as AdobePhotoshop
• Skill in both electronic and hard copymarkup(Acrobat, tracked changes in Microsoft Word, standard editorial and proofreading symbols)
• Knowledge and experience with desktop publishing (DTP) software applications (MadCapFlare, AdobeFrameMaker, AdobeInDesign, 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 unitdeliverablesto 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
• Bachelor's Degree in Information Technology, Business, Marketing, or other related field

Note: This is a W2 contract role – C2C & 3rdparty candidates WILL NOT be considered