Sr. Technical Writer Job at InstantServe LLC in San Jose
InstantServe LLC, San Jose, CA, US, 95199
Role: Sr. Technical Writer
Work Arrangement: Onsite
Type: Full Time Role
Complete Description:
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, labeling, 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 labeling.
• Contributes to new product development and design change activities in the areas of labeling design/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 and 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. In Summary: 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 must have a Bachelor's degree or Master's in engineering, Science, or a related field . En Español: El escritor técnico será responsable de crear y gestionar la documentación para el departamento de Investigación y Desarrollo. Este puesto requiere una comprensión exhaustiva de los procesos de desarrollo de dispositivos médicos, requisitos de documentación y cumplimiento regulatorio. • Colabora con equipos interfuncionales para recopilar información y garantizar que la documentación sea precisa, completa y coherente. • Gerenciará el proceso de revisión y aprobación de toda la documentación técnica para asegurar el cumplimiento de los requisitos regulatorios. • Garantizará que la Documentación esté actualizada, exacta y accesible a todas las partes interesadas. • Asistirá en el desarrollo e implementación de estándares, políticas y procedimientos de documentación. • Proporcionará un resumen semanal de actividades, creará planes de proyectos para tareas asignadas, priorizará y comunicará efectivamente actualizaciones a los clientes. • Seguirá buenas prácticas (PIB) para toda documentación creada/revisada y se mantendrá al día sobre todo el entrenamiento requerido. • Excelentes habilidades de comunicación escrita y verbal con la capacidad para comunicar eficazmente información técnica a una variedad de públicos.
Work Arrangement: Onsite
Type: Full Time Role
Complete Description:
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, labeling, 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 labeling.
• Contributes to new product development and design change activities in the areas of labeling design/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 and 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. In Summary: 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 must have a Bachelor's degree or Master's in engineering, Science, or a related field . En Español: El escritor técnico será responsable de crear y gestionar la documentación para el departamento de Investigación y Desarrollo. Este puesto requiere una comprensión exhaustiva de los procesos de desarrollo de dispositivos médicos, requisitos de documentación y cumplimiento regulatorio. • Colabora con equipos interfuncionales para recopilar información y garantizar que la documentación sea precisa, completa y coherente. • Gerenciará el proceso de revisión y aprobación de toda la documentación técnica para asegurar el cumplimiento de los requisitos regulatorios. • Garantizará que la Documentación esté actualizada, exacta y accesible a todas las partes interesadas. • Asistirá en el desarrollo e implementación de estándares, políticas y procedimientos de documentación. • Proporcionará un resumen semanal de actividades, creará planes de proyectos para tareas asignadas, priorizará y comunicará efectivamente actualizaciones a los clientes. • Seguirá buenas prácticas (PIB) para toda documentación creada/revisada y se mantendrá al día sobre todo el entrenamiento requerido. • Excelentes habilidades de comunicación escrita y verbal con la capacidad para comunicar eficazmente información técnica a una variedad de públicos.