Objectives of this Role:
- Develop comprehensive process documentation and development documentation that meets medical device standards (ISO 13485).
- Obtain a top-line understanding of products, the processes by which they are made and the underlying science behind them by working with technical experts in order to thoroughly document all key elements.
- Write descriptive, user-friendly content that meets the needs of product and process documentation within the context of FDA documentation requirements.
- Evaluate current content and develop innovative approaches for improvement.
Daily and Monthly Responsibilities:
- Research, outline, write, and edit new and existing content, working closely with the engineering team to understand project requirements.
- Independently gather information from subject matter experts to develop, organize, and write technical reports, technical specifications, process documentation, protocols and reports. The intent is to free up key technical resources to conduct research and development while the technical writer produces the corresponding high-quality documentation.
- Use photographs, drawings, diagrams, animation, and charts that result in intuitive, user friendly documentation.
- Analyze current document content and make improvements as necessary.
- Serve as a behavioral role model for technical documentation creation.
Skills and Qualifications:
- Bachelor’s degree in relevant technical field.
- 2-4 years’ industry experience as an effective technical writer that is compliant to ISO 13485 standards.
- Proven ability to quickly learn and understand complex topics.
- Previous experience writing documentation and procedural materials for auditable medical device design history files & master records.
- Superior written and verbal communication skills, with a keen eye for detail.
- Experience working closely with engineers to extract content from their experiments and use it to create reports/documents.
Benefits offered:
- Paid time off
- Health insurance
- Dental insurance
- Retirement benefits or accounts
- Others
