Technical Writer for Medical Devices & ISO 13485 Docs

TAE Life Sciences; Irvine (CA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) with company match

Paid vacation & sick time

Equity potential

HQ in Southern California

Job summary

TAE Technologies in Irvine, CA seeks a technical writer and document control specialist to create and maintain technical documentation, specifications, IFUs, and manuals for mechanical and electronic systems, aligned with ISO 9001/13485 requirements.

Work with engineers and scientists to review drawings, capture design details, and ensure traceability from concept through testing, while managing documents in a controlled system.

Qualifications

• Minimum 3 years of experience in technical writing, medical background preferred.
• Excellent technical writing skills for mechanical, electrical and high-tech products.
• Practical knowledge of QA concepts and Document Control.
• Ability to work with others and obtain information for accurate part specifications.
• Experience with industrial vendors for data, quality docs and certifications.
• Hands-on experience managing docs per ISO 9001 quality system.

Responsibilities

• Create and maintain technical documentation, specs, product manuals, IFUs, SOPs and training materials.
• Review drawings with engineers and scientists and compile part specifications for procurement.
• Document design, testing, requirement traceability and inspection.
• Maintain organized documents and drawings according to Document Control and QA principles.

Skills

Technical writing

Quality Assurance

Document Control

CAD familiarity

Adobe software

SOP drafting

Vendor liaison

Team collaboration

Education

B.S. in journalism/English/communications

B.S. in engineering/CS/medicine (preferred)

Tools

AutoCAD

SolidWorks

Job description

TAE Technologies in Irvine, CA seeks a technical writer and document control specialist to create and maintain technical documentation, specifications, IFUs, and manuals for mechanical and electronic systems, aligned with ISO 9001/13485 requirements.

Work with engineers and scientists to review drawings, capture design details, and ensure traceability from concept through testing, while managing documents in a controlled system.