As part of the technical product management group in the software engineering department, the Technical Writer will work with engineering teams to produce and improve documentation for purposes including user guides, departmental information, API references, and software product requirements.
A technical writer in our team will need to be able to understand both the business requirements and the technical details of the software to be able to effectively produce high quality documentation. They will need to communicate with multiple stakeholders and engineering team members and examine the software to help derive information for documentation.
- Investigate and learn the business processes and software systems functionalities that need documentation.
- Update user guides for internal operations users to cover gaps and new functionality.
- Maintain API documentation in wiki for use by external business partners.
- Create documentation for engineering team members such as training plans, departmental practice descriptions, and other onboarding documentation.
- Help merge project requirement documents into baseline product requirement documentation.
- Retroactively produce baseline product requirement documentation for existing functionalities.
- Help ensure traceability is established across documentation for project deliverables.
- Generate documentation exports from Confluence, Jira, and TestRail using a custom-developed tool for controlled Document Change Orders.
- Prepare release notes for external facing features.
- Assemble reports needed for regulatory compliance requirements including FDA 21 CFR Part 11, GCP, CAP / CLIA, HIPAA, CE, GDPR, etc.
- Introduce departmental practice changes and tools that will improve documentation quality and organization throughout engineering.
- Performs other duties as assigned.
- BS or higher in related major or equivalent industry experience
- 2 years of experience in writing technical software documentation for end-to-end use
- Experience working in a regulated environment – preferably dealing with similar compliance requirements for a medical device or IVD company: FDA 21 CFR Part 11, GCP, CAP / CLIA, HIPAA, CE mark, GDPR, etc.
- Experience writing instructions for end-to-end use of business software
- Experience understanding software implementations and writing examples for structured data input/output (JSON, XML).
- Experience working directly with engineering and product management teams as part of software development process.
Knowledge, Skills and Abilities
- Excellent written communication skills to produce clear, concise and correct technical documentation
- Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures
- Familiarity with documentation control and collaboration software like Confluence
- Familiarity with the Software Development Life Cycle
- Understanding of systems integrations and web services using JSON or XML
- Preferably have the ability to read and understand object-oriented code, especially Java
- Useful domain knowledge:
- LIMS, LIS, LES, and/or ELN (especially LabVantage)
- Genetics and bioinformatics
- Genomics data analysis
- Laboratory processes and instrumentation
- Laboratory software compliance requirements
Physical Demands & Work Environment
- Duties are typically performed in an office setting and environment.
- This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material.
- Duties may require working outside normal working hours (evenings and weekends) at times.