Technical Writer - Product Development (Dental Devices)

Glidewell Dental; Irvine (CA); On-site; USD 41,000 - 59,000; Full time

Job summary

Glidewell Dental in Irvine, CA is seeking a Technical Writer to translate complex technical and scientific information into clear documentation, including SOPs, test methods, IFUs and reports. You will collaborate with R&D, Manufacturing and Regulatory teams to produce product documentation that supports regulatory compliance and successful market launch.

A Bachelor's degree and at least four years of medical device documentation experience are required; knowledge of 21 CFR 820 is essential.

Qualifications

• Bachelor's degree in engineering, science, or a related technical field.
• Minimum four years of direct documentation experience in medical devices, software or technical industries.
• Knowledge of 21 CFR 820.
• Familiarity with US and international regulations for medical devices.
• Experience creating SOPs and manufacturing documentation.

Responsibilities

• Collaborate with R&D, Manufacturing and Marketing to document test methods, reports, labels, and design files.
• Conduct literature research and interviews to support white papers and technical documents.
• Prepare regulatory-aligned documentation for submissions and product labeling.
• Create SOPs and manufacturing instructions and ensure alignment with quality standards.
• Coordinate with regulatory teams for international submissions.
• Maintain up-to-date technical submission files and project planning documents.

Skills

Technical writing

Medical device documentation

Regulatory knowledge

Cross-functional collaboration

Literature research

Interviewing technical staff

SOP creation

Documentation of test methods

Education

Bachelor's Degree in Engineering, Science or related technical field

Job description

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.

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: $30.00 to $43.00/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.