Job Description
Job Description
Job Title:
Spec 2, Technical Writing
Address:
San Diego, California
Schedule:
Monday - Friday, 8:00 AM - 5:00 PM (Full Time)
Job Description
The Senior 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 include:
• Create, edit, and maintain customer and internal facing technical documentation, including user manuals, installation guides, troubleshooting guides, and update 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 for both quality and technical documentation.
• 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.
• 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.
• Provide guidance and mentorship to junior technical writers and other team members.
• Manage fast-moving documentation projects, including timelines, resources, and deliverables.
• Stay current with industry trends, regulatory changes, and best practices in technical writing and medical device documentation.
Critical Information
This role requires experience in a regulated industry such as medical devices or pharmaceuticals, extensive experience with regulatory compliance processes, and strong collaboration skills. Candidates should have five or more years of experience writing and editing technical documents and the ability to effectively manage multiple projects with excellent follow-up.
Benefits:
• Benefits are available to full-time employees after 90 days of employment.
• A 401(k) with company match is available to full-time employees after 1 year of service.