MicroAire Surgical Instruments LLC needs a Software Documentation Specialist to support review and translate key documents for medical device software validation and cyber security compliance.
Requirements
- AI translation platforms (e.g., DeepL, Google Translate API)
- Document tools (Adobe Acrobat, MS Word, XML editors)
- Diagram tools (e.g., Visio, Lucidchart) for working with flowcharts
- Familiarity with software development terminology, source code commenting, and cybersecurity frameworks
- Knowledge of cybersecurity documentation standards (e.g., FDA Guidance, IEC 81001-5-1, IEC 62443)
Responsibilities
- adapt/create cyber security documentation for new products from multiple document sources and regulatory guidance.
- Supports the software validation process for medical devices.
- Translates software documentation from French to English with support of an AI translation tool.
- Reviewing and editing machine-translated (AI-generated) documentation
- Creating cybersecurity documentation or working with secure systems
Other
- bi-lingual English/French
- Translating technical or engineering documentation (software, flowcharts, technical manuals)
- Working within regulated industries such as medical devices, pharmaceuticals is a plus
- Bi-lingual French/English a plus
- Strong organizational and editing skills to ensure clarity and consistency in translated and original documents
