Job Description

Job Description

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:

• Experience working in a regulated industry such as medical devices or pharmaceuticals .

• Extensive experience with regulatory compliance processes. Strong background in supporting regulatory requirements to ensure adherence to regulatory guidelines.

• Demonstrated ability to be highly collaborative with marketing, clinical, quality, and regulatory reviewers.

• Five or more years writing and editing hardware/software user guides (print and online) and other technical product documentation.

• Ability to effectively manage the delivery of prioritized tasks.

• Ability to demonstrate a high level of initiative to gather information for developing documentation.

• Ability to work independently with minimal supervision.

• Effective at thinking independently and solving problems with product core team members.

• Ability to work under compressed deadlines and must be able to deal with unresolved situations, frequent project changes, delays, or other events.

• Ability to handle multiple projects with excellent follow-up and project management skills.

• 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 with SAP, Oracle, or similar enterprise resource planning (ERP) system is a plus.

• 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 (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.

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