Technical Writer - Medical Device Product Development

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

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.