- Technical Writer/editor 3
- VIVA USA INC
- 6 days ago
Looking for USC OR GC willing to work on W2
Seeking an experienced, self-motivated Technical Writer to develop user assistance content for in vitro (IVD) diagnostics instruments and software within the client , Laboratory Diagnostics, R&D, Content & Labeling Department.
This position requires working with a team and on multiple deliverables to support commercial products and development projects.
The strongest candidates will have experience developing technical content using XML or structured Framemaker, as well as experience interpreting user needs to develop content for both software and hardware. Knowledge of Product Labeling as defined by the FDA 21 CFR 809, EU IVDR, or international regulatory organizations, as well as of agile development or scrum framework is beneficial but not required.
Responsibilities include the following:
Collaborating with cross-functional teams in an agile software development environment.
Developing, verifying, and managing content versions and reviews throughout the product lifecycle, under the guidance of a senior writer or project manager.
Developing content consistent with company branding and style guidelines.
Participating in scrum activities and sprints to manage tasks and track progress.
Reading and understanding scientific and engineering information, design requirements, test specifications, product prototypes, and usability study results.
Understanding user interaction and task workflows for software and hardware.
Confirming content accuracy using software emulators or diagnostics instruments.
Developing concept and task topics using XML to create user assistance and troubleshooting deliverables for laboratory diagnostic professionals.
Developing content with translation into other languages in mind.
Understanding and implementing relevant procedures and work instructions within the company Quality Management System.
Supporting audits and other regulatory investigations as appropriate.
Team deliverables include operator's guides, quick guides, online help, release notes, and other technical publications for laboratory diagnostics technicians as well as automation and network IT professionals.
Education and Experience:
The candidate should have a BS/BA in a related discipline.
A minimum of 5-8 years of technical writing experience in a related field and successful demonstration of the responsibilities and knowledge presented above.