What are the responsibilities and job description for the Technical Writer position at Altimate Medical Inc?
We are seeking a skilled and detail-oriented Technical Writer to join our team in the Durable Medical Equipment (DME) and Patient Positioning Industries. As a Technical Writer, you will be responsible for creating, editing, and maintaining a wide range of technical documentation for our medical devices and equipment. You will work closely with engineers, product managers, and regulatory specialists to ensure that documentation complies with industry standards and provides clear, accurate, and user-friendly information.
ESSENTIAL FUNCTIONS
- Document Creation & Maintenance:
- Develop, write, and maintain user manuals, installation guides, operation instructions, and maintenance procedures for products.
- Create and update product documentation such as Design History Files (DHF) to ensure accuracy, clarity, and compliance with regulatory requirements (e.g., ISO, FDA).
- Write standard operating procedures (SOPs), work instructions, and training materials for internal teams and end-users.
d. Responsible for compiling and maintaining documentation in Grand Avenue
- Collaboration & Coordination:
- Collaborate with product development, engineering, and regulatory teams to gather technical information and ensure correct and consistent product details.
- Review and edit technical content from subject matter experts to ensure clarity and alignment with brand and regulatory guidelines.
- Work with the marketing, engineering, and quality teams to integrate relevant compliance language and product features into the documentation.
- Regulatory Compliance:
- Ensure all documentation adheres to relevant industry regulations (e.g., 21 CFR Part 820, ISO 13485, IEC 60601).
- Quality Assurance & Testing:
- Review and proofread technical documents for accuracy, grammar, and consistency.
- Assist with Verification and Validation Testing and work closely with the product team to ensure the documentation complies with regulatory standards.
- Continuous Improvement:
- Stay updated on industry trends, regulatory changes, and advancements in medical equipment to continuously improve documentation practices.
- Provide feedback and recommendations for improving product manuals and documentation processes.
6. General Requirements:
a. Follows safety procedures and maintains a clean and safe work environment.
b. Utilizes appropriate personal protective equipment where/when necessary.
c. Contributes to a respectful, non-hostile, non-violent work environment.
d. Understands the purpose, value, and impact work has on product customers and users.
e. Other duties as assigned.
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