Sr Technical Writer

Company: BioFire Diagnostics
Location: San Jose
Posted on: May 24, 2023

Job Description:

The CompanySpecific Diagnostics, a BioM--rieux company, is a medical device company that has developed a rapid antimicrobial susceptibility test (AST) system that delivers phenotypic AST directly from positive blood cultures. Our mission is to provide innovative and reliable medical devices that improve patient outcomes and enhance the life of people around the world. Our team of highly skilled professionals is dedicated to excellence in research, development and manufacturing and we are looking for a Technical Writer jo Join our Research and development department.Job OverviewThe 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, test protocols, verification and validation reports, instruction for use and user manuals.
• Collaborate with cross-functional teams to gather information and ensure documentation is accurate, complete, and consistent.
• Manage the review and approval process for all technical documentation to ensure compliance with regulatory requirements.
• Ensure documentation is up-to date, accurate and accessible to all stakeholders.
• Assist in development and implementation of documentation standards, policies and procedures.KNOWLEDGE, EXPERIENCE & SKILLS
  • Bachelor's degree or Master's in engineering, Science, Technical Writing, 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.If you are interested in this opportunity, please submit your resume and a cover letter for consideration. We look forward to hearing from you.

Keywords: BioFire Diagnostics, San Jose , Sr Technical Writer, IT / Software / Systems , San Jose, California