Senior Medical Device Technical Writer

Grifols; San Diego (CA); Presencial; USD 90.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical

Dental

Vision

Life Insurance

PTO

401(k) match

Tuition reimbursement

Descripción de la vacante

Grifols in California is seeking a Technical Writer II to develop and revise operator manuals, service manuals, and technical bulletins for instrumentation and software. You will gather information from cross-functional teams and ensure documentation adheres to quality standards and regulatory requirements.

The role requires five years of end-user documentation experience, familiarity with medical device regulations, and proficiency in FrameMaker, Illustrator/Visio, and Confluence/Jira for

Formación

• Minimum five years of experience writing end-user software or hardware instructions.
• Experience in the medical device industry preferred.
• Experience in federally regulated environments (FDA/UMDR).
• Bachelor's degree in English or Technical Communication or related field.
• Familiar with MS 365, SharePoint, FrameMaker, and Acrobat Pro.

Responsabilidades

• Revise and edit legacy product documentation including operator manuals, service manuals, and technical bulletins.
• Manage translation projects with vendors and perform translation reviews for consistency with formatting and layout.
• Effectively manage multiple projects, changes in scope, and shifting priorities to meet deadlines.
• Process documents through the electronic documentation control system (LSQM).
• Maintain version control, change history, and traceability for all deliverables.
• Ensure documentation is accurate, complete, and compliant with regulatory/QSR requirements.
• Create and edit documentation complying with FDA, IVDR, and EU MDR requirements.
• Collaborate with cross-functional peers to resolve questions during development.
• Continuously review the document development process to ensure labeling quality.

Conocimientos

Advanced writing

Editing

Organized

Multitasking

Global collaboration

Change control

Documentation tools

Medical terminology

Educación

Bachelor's in English/Technical Communication

Herramientas

Microsoft 365

SharePoint

FrameMaker

Acrobat Pro

Visio

SnagIt

Confluence

Jira

Descripción del empleo

Grifols in California is seeking a Technical Writer II to develop and revise operator manuals, service manuals, and technical bulletins for instrumentation and software. You will gather information from cross-functional teams and ensure documentation adheres to quality standards and regulatory requirements.

The role requires five years of end-user documentation experience, familiarity with medical device regulations, and proficiency in FrameMaker, Illustrator/Visio, and Confluence/Jira for