Technical Writer - Medical Devices (contract) at PathAI
PathAI's mission is to improve patient outcomes with AI-powered pathology. Our platform promises substantial improvements to the accuracy of diagnosis and the efficacy of treatment of diseases like cancer, leveraging modern approaches in machine learning. Rigorous science and careful analysis is critical to the success of everything we aspire to do. Our team, comprising diverse employees with a wide range of backgrounds and experiences, is passionate about solving challenging problems and making a huge impact.
We're looking for a skilled Technical Writer to focus on creating comprehensive world class product documentation for our AI powered clinical pathology Image Management System, In Vitro Diagnostics (IVDs) including Companion Diagnostics.
This is a 6 month contract with potential to convert to a full time position if there is mutual interest.
What you’ll do:
- Collaborate with key members of a cross functional team including Product, Project, and Engineering Managers, Technical Leads, Software engineers, Regulatory and Clinical Affairs, legal, marketing and quality personnel.
- Contribute to development of user facing documentation for our medical devices, including but not limited to the Instructions for Use, Troubleshooting Guide and Quick Reference Guides and meeting submission timelines.
- Translate technical information and system requirements into text and graphics comprehensible by the end user.
- Work actively with Engineering, Product Management, and Regulatory to ensure alignment between user needs, system behaviour, and documentation.
- Participate in Systems Engineering processes of risk assessment, human factors assessments, clinical studies and requirements according to regulations.
What you’ll need:
- Experience working on documentation such as instructions for use and labeling for SaMD (Software as a Medical Device), ideally Class II or III in USA. Content localization and global experience is a plus!
- Experience working with MadCap Flare
- An insatiable intellectual curiosity and the ability to learn quickly in a complex space
PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.
PathAI does not accept unsolicited submissions from third-parties.