Technical Writer

Title: Technical Writer

Location: Work from Home

Note: This is a W2 contract role â 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 productâ 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 â C2C & 3rd party candidates WILL NOT be considered

#ALINE11