Technical Writer - Product Development (Medical Device)

Description

Position at Glidewell Dental

Essential Functions:

• 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.

Minimum Qualifications:

• 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.

Pay range: $30.44-$40.59/hrExact 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 recruitment@glidewelldental.com. Please indicate the specifics of the assistance needed.

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