Technical Writer - Product Development

$62,858 - $93,600/Yr

Prismatik - Irvine, CA

Full-time

Irvine, CA

About the position

The Technical Writer position at Prismatik involves collaborating with product teams to create and maintain technical documentation that supports product development and compliance with industry standards. The role requires generating various documents such as protocols, technical reports, and marketing materials, while ensuring adherence to quality systems and regulatory requirements.

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 a Bachelor's degree with one year of experience.
• Experience with document control systems such as ETQ or CatsWeb is a plus.
• Knowledge of 21 CFR 820 is a plus.
• Experience working in an FDA regulated industry is a plus.
• Familiarity with industry standards such as ANSI and ISO is a plus.

Benefits

• Medical
• Dental
• Vision
• 401K with company match
• Company-paid life insurance
• Additional onsite dental services
• Vacation
• Holiday and sick time
• Employee gym with fitness classes and meditation room
• Employee medical/wellness center with massage therapy and acupuncture
• Two company subsidized cafes
• Internet cafes
• Employee lounges with big screen TVs and game tables
• Fun company sponsored events
• Diverse work environment with over forty nationalities represented