Technical Writer — ISO 13485 Medical Tech Documentation

TAE Technologies, Inc.; Irvine (CA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401K with company match

Paid vacation + sick time

Wellness program

Parental leave

Job summary

TAE Technologies, Inc. in Irvine, CA is seeking a Technical Writer to collaborate with engineers and scientists to produce technical documentation, specifications, product manuals, IFUs, and SOPs.

You will ensure documentation aligns with ISO 9001/13485 quality systems and maintain project files. Candidates should have at least 3 years in technical writing for high-tech devices, strong CAD/document control concepts, and experience with medical industry quality systems.

Qualifications

• Minimum 3 years of technical writing experience, preferably in medical or high-tech products.
• Strong writing skills across mechanical, electrical, and related domains.
• Practical knowledge of Quality Assurance and Document Control.

Responsibilities

• Collaborate with engineers and scientists to create technical documentation, specifications, product manuals, IFUs, service and operation manuals.
• Maintain documents and drawings per ISO 9001/13485 requirements.
• Review drawings and compile specifications for procurement; support documentation of design, tests, and inspections.

Skills

Technical writing

Documentation control

Communication skills

Team collaboration

Medical industry knowledge

Education

BS in journalism/English/communications

BS in engineering/CS/medicine (preferred)

Tools

CAD (AutoCAD/SolidWorks)

Adobe Software

Data entry/macros

Job description

TAE Technologies, Inc. in Irvine, CA is seeking a Technical Writer to collaborate with engineers and scientists to produce technical documentation, specifications, product manuals, IFUs, and SOPs.

You will ensure documentation aligns with ISO 9001/13485 quality systems and maintain project files. Candidates should have at least 3 years in technical writing for high-tech devices, strong CAD/document control concepts, and experience with medical industry quality systems.