Title - Senior Technical Writer
Sanjose CA Hybrid
Duration- temp - Permanent after 180 days
US Citizens and GC Holders only No c2c
Note -
R&D team is 60 people, developing products and document everything that is done. A lot of writing and the team may not be very experienced. Protocols and reports. Helping writing the documents. IVD experience / medical device experience is required. Worked in a lab atmosphere. Also manage changes, write SOPs for lab, design specs, protocols. Coordinate a change like when a product changes, they follow the change "like a project management" coordinate those who need to write an impact assessment, why we're doing the change, submit, keep track, how is change effecting my function, a list of actions,
Technical background a must. Not English writing. FDA required. ISO preferred. Taking a presentation and writing it for the group. DHF.
Job Overview
- The Sr. technical Writer will be responsible for creating and managing documentation for the Research and Development department. This position requires a thorough understanding of medical device development processes, documentation requirements and regulatory compliance. The technical Writer will work closely with cross-functional teams, including Engineers, Scientists, Regulatory Affairs and Quality Assurance, to ensure accurate and timely documentation is produced.
Primary Duties :
Develop and maintain technical documentation that meets organizational standards, including but not limited to, standard operating procedures, procedures, design specifications, study protocols, study reports, verification and validation reports, instruction for use and user manuals.Coordinates change requests within change management process for R&D (change in specifications, labelling, SOP)Reviews and audits other technical publications deliverables and consistently delivers quality documentation.As regulations change and quality systems are merged / aligned, execute the creation / refinement of documentation.Creates end-user regulatory complaint product labelling.Contributes to new product development and design change activities in the areas of labelingdesign / release, technical writing, development of artwork / images and development.Collaborates with cross-functional teams to gather information and ensure documentation is accurate, complete, and consistent.Manages the review and approval process for all technical documentation to ensure compliance with regulatory requirements.Ensures documentation is up-to date, accurate and accessible to all stakeholders.Assists in development and implementation of documentation standards, policies and procedures.Provides weekly summary of activities, creates project plans for tasks assigned, prioritizes, and effectively communicate updates to customers.Follows Good Document practices (GDP) for all documentation created / reviewed and staying current on all required training.Knowledge, Experience, Skills :
Bachelor's degree or master's in engineering, Science, or a related field.3-5 years of experience in technical writing for medical device development of complex systems including hardware, software, and reagents.Experience working in a regulated industry such as FDA or ISO.Experience with electronic document management software (Livelink or similar) for tracking an processing document change requests.Experience with Quality Management System.Experience with Product Development and Design Control Processes.Proficient in documentation tools such as Office, Adobe Acrobat and content management systems.Excellent written and verbal communication skills with the ability to effectively communicate technical information to a variety of audiences.Strong attention to detail and accuracy.Ability to work collaboratively in a cross-functional team environment.Ability to prioritize and manage multiple projects simultaneously.
