Technical Writer - Product Development (Dental Devices)

Prismatik•Irvine, CA

18d•$30 - $43•Onsite

About The Position

We’re looking for a Technical Writer to help turn complex technical and scientific information into clear, well-structured documentation. From SOPs and test methods to IFUs and technical reports, you’ll play a key role in making sure our products are accurately documented and ready for market.

Requirements

Bachelor’s Degree in Engineering, Science or a related technical field.
Minimum of four (4) years of direct documentation experience in the medical device, software or other technical industry.
Knowledge of 21 CFR 820.
Knowledge of current US and International regulations as it pertains to documentation.
Knowledge of current US and International standards governing medical devices.

Responsibilities

Collaborates with Research & Development, Manufacturing and Marketing teams to accurately document test methods, technical reports, labels, and other design file documents for specific market products.
Performs independent literature research, analyzes data and conducts interviews for in-depth white papers and other scientific/technical documents.
Conducts extensive literature and industry research, analyzes results and compiles information into meaningful reports for various audience types.
Performs interviews with scientific and technical staff, and translates information onto detailed documents.
Creates all essential documentation for technical device design histories, manufacturing BOMs and routers.
Works closely with regulatory and quality staff to ensure product documentation supports regulatory and quality standards.
Works with project and product managers to document product alignment with business strategy.
Designs and creates protocols, technical reports, test methods, manufacturing instructions, project planning documents and labeling documents.
Designs marketing documents, IFUs and labels according to the Quality System.
Supports project managers with action items, project planning documentation, and coordinates with the project team for successful launch of product.
Creates Standard Operating Procedures (SOPs) for new procedures; maintains and updates current SOPs.
Creates technical submission files and coordinates with regulatory team on submission/approval process.
Collaborates with regulatory team to assist with international submissions; creates additional required documents as new regulations arise in different countries.
Coordinates, validates, and assists with documenting test results.
Performs other related duties and projects as business needs require at direction of management.