Instrument Documentation Writer - R&D Instrument Systems
About The Position
Grifols Diagnostic Solution is seeking an Instrument Documentation Writer in San Diego, CA. This role will be reporting to the Senior Manager, Verification and Validation. This position will provide technical writing support for instrument and software operator manuals, technical bulletins, specifications, and training materials. As a member of the R&D Instruments group, this position will take in technical information from multiple cross-functional groups to develop instrumentation manuals (operators manuals, service manuals), field technical bulletins, and training materials. We are seeking individuals who have at least a Bachelor’s degree, preferably in English or Technical Communication, similar related fields. Plus, a minimum of five years of experience writing end-user software or hardware instructions. Experience in the medical device industry and working in a federally regulated environment (FDA/UMDR) are preferred.
Requirements
- Advanced writing/editing skills
- Self-directed and highly organized
- Ability to manage multiple priorities
- Excellent communication skills
- Cross-functional collaborative nature
- Proven ability to work with global stakeholder
- Familiarity with quality processes and principals
- Product lifecycle management software experience
- Medical terminology experience
- Product development workflow experience
- Hands-on experience with instrumentation and software
- Bachelor's degree, preferably in English or Technical Communication, similar related fields.
- Minimum five years of experience writing end-user software or hardware instructions.
Nice To Haves
- Experience in the medical device industry preferred
- Experience working in a federally regulated environment (FDA/UMDR)
Responsibilities
- Revise and edit legacy product documentation as required, including but not limited to user’s guides, service manuals, and instructions for use (IFUs).
- Partner with our software translation vendor to perform translation on the instrument and verify for consistency
- Manage translation projects with the translation vendor and perform translation reviews for consistency with formatting and layout.
- Effectively manage multiple projects, changes in project scope, and shifting priorities to maintain project requirements and ensure deadlines are met.
- Process documents through the electronic documentation control system (LSQM).
- Manage all aspects of document development and assist in production release, including draft reviews.
- Coordination of translations for documentation and software development.
- Ensure compliance of labeling with all applicable regulatory/QSR requirements.
- Create and edit documentation in compliance with requirements from applicable regulatory bodies (FDA, IVDR, EUDR) and the European Union (EU Medical Device Regulation).
- Deliver supporting documentation to the labeling product, including labeling design plans, trace documents, technical reviews, and verification deliverables.
- Collaborate with departmental and cross-functional peers to ensure proper resolution to questions and issues during the document development process.
- Continually review the document development process to ensure quality in labeling output.
- Assist Validation team in the validation of Manuals
- Support internal technical editors in the translation process
- Support software user interface translation process
- Keep track of documentation through the entire development process while adhering to time lines, maintaining revision control, maintaining change lists, and managing reviews
- Ensure that documentation is accurate, complete, meets specifications, and adheres to standards for quality and style.
Benefits
- Medical
- Dental
- Vision
- PTO
- up to 5% 401(K) match
- tuition reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
