Technical Writer - R&D

Research and Development (Prismatik, a Glidewell Company) Irvine, California


Description

Position at Prismatik

Essential Functions:

  • Generates, maintains, and updates protocols, technical reports, test methods, manufacturing instructions, project planning documents, and labeling documents.
  • Creates and maintains design history files, manufacturing bill of materials (BOMs),routers and labels.
  • Creates memos, marketing documents, instructions for use (IFUs), and labels according to the Quality System.
  • Collaborates with Research &Development (R&D) and project management team to determine project action items, documentation, and meeting schedules to support product launches.
  • Prepares project-related documentation such as project plans; utilize D365 or similar platforms to create part lists etc.
  • Creates, maintains, and updates procedures.
  • Assists in the preparation of technical manuscripts, white papers, and patent documentation. Works closely with R&D teams to ensure clarity, accuracy and alignment with publication and intellectual property requirements.
  • Collaborates with engineers, scientists, regulatory and quality staff in the company to ensure accuracy and completeness of all documentation.
  • Support internal regulatory requirements related to documentation and on assigned projects.
  • Ensures all testing procedures and documentation comply with ISO, ASTM and other applicable standards.
  • Provides documentation in support of internal and external audits, and knowledge transfer activities. 
  • Performs other related duties and projects as business needs require at direction of management.
Minimum Qualifications:
  • Associate’s degree in a scientific or engineering field with a minimum of four (4) years of technical documentation experience; or Bachelor’s degree in a scientific or engineering field with a minimum of two (2) years of technical documentation experience.
  • Experience in working in dental or medical device industry as a technical writer.
  • Experience with the use of electronic document control systems such as ETQ or CatsWeb, a plus.
  • Knowledge of 21 Code of Federal Regulations (CFR) 820 a plus.
  • Experience working in a Food & Drug Administration (FDA) regulated industry, a plus.
  • Experience with industry standards such as American Society for Testing and Materials (ASTM), American National Standards Institute (ANSI) and International Organization for Standardization (ISO) a plus.
Pay range: $30.44-$40.58/hr
Exact compensation may vary based on skills and experience.
This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.

Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at Glidewell!

In addition are the following generous employee 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, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more!

Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected]. Please indicate the specifics of the assistance needed.

Note to Current employees: Please apply through Employee Transfer Application to complete the transfer request form.