Technical Writer - Product Development

$62,858 - $93,600/Yr

Prismatik - Irvine, CA

Full-time - Mid Level

Irvine, CA

About the position

The Technical Writer position at Prismatik involves collaborating with product teams to create and manage technical documentation for various projects and products. The role focuses on generating essential documents such as test methods, technical reports, and labeling documents, ensuring compliance with FDA regulations and industry standards.

Responsibilities

• Collaborates with product teams and stakeholders to document test methods, technical reports, labels, and other documents.
• Generates protocols, technical reports, test methods, manufacturing instructions, project planning documents, and labeling documents.
• Creates design history files and manufacturing bill of materials (BOMs) and routers.
• Designs marketing documents, instructions for use (IFUs), and labels according to the Quality System.
• Collaborates with project management to determine project action items, documentation, and meeting schedules for product launches.
• Creates, maintains, and updates procedures.
• Performs other related duties and projects as directed by management.

Requirements

• Associate's degree in a scientific or engineering field with a minimum of two years of technical documentation experience, or Bachelor's degree with one year of experience.
• Experience with document control systems such as ETQ or CatsWeb.
• Knowledge of 21 Code of Federal Regulations (CFR) 820.
• Experience working in a Food & Drug Administration (FDA) regulated industry.
• Familiarity with industry standards such as ANSI and ISO.

Nice-to-haves

• Experience with document management systems.
• Knowledge of FDA regulations.