Medical Device Technical Writer

The Technical Writer will be responsible for developing, writing, and maintaining comprehensive technical documentation for our 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 will have extensive experience in the medical device industry and the ability to work effectively with cross-functional teams.

Key Responsibilities :

• Create, edit, and maintain customer and internal facing technical documentation, including user manuals, installation guides, troubleshooting guide, upgrade / downgrade instructions for various country regulatory submissions.
• Ensure all documentation meets regulatory requirements, industry standards, and company policies.
• Create illustrations, flow charts, diagrams, 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. Also 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.

Qualifications :