We are a Los Angeles Software and IT staffing agency specializing in recruiting Software Documentation Engineers for companies that fall into the healthcare and biotechnology industries.
Our client is a pioneering health technology company redefining the future of patient care through AI-powered clinical decision support systems. Their intelligent platform leverages automation, machine learning (ML), and data-driven analytics to transform traditional medical clinics into digitally integrated, vertically scalable health systems.
The company’s mission is to enhance clinical workflows, diagnostic accuracy, and patient outcomes through advanced technology that integrates electronic health records (EHR), predictive algorithms, and clinical data management systems. As a Software Documentation Engineer, you will play a key role in bridging the gap between complex AI-driven software architectures and the healthcare professionals who use them — ensuring clarity, accuracy, and compliance across every product release.
Typical Duties and Responsibilities
As a Software Documentation Engineer, you will be responsible for authoring, editing, and maintaining comprehensive technical documentation for software systems used in regulated healthcare environments.
Your day-to-day responsibilities will include:
- Develop, organize, and maintain detailed software documentation, user manuals, release notes, and technical specifications for AI-enabled clinical decision support software.
- Collaborate with software developers, data scientists, QA engineers, regulatory specialists, and clinical subject matter experts (SMEs) to translate complex system functionalities into clear, compliant documentation.
- Create and manage software requirement specifications (SRS), design history files (DHF), validation protocols, and software traceability matrices (STM) in alignment with FDA 21 CFR Part 820 and ISO 13485 standards.
- Prepare regulatory submission documentation in compliance with IEC 62304 (Medical Device Software Life Cycle), ISO 14971 (Risk Management), and HIPAA data privacy requirements.
- Document AI/ML model training workflows, data labeling procedures, and algorithm version control in accordance with Good Machine Learning Practice (GMLP) guidelines.
- Maintain API documentation and developer guides for internal and external integrations using tools such as Swagger/OpenAPI, Postman, and Doxygen.
- Manage configuration control and document revisions through PLM and QMS systems (MasterControl, Greenlight Guru, Arena PLM, Jira, Confluence).
- Produce high-quality, visually engaging content using Adobe FrameMaker, MadCap Flare, Microsoft Word, Snagit, and Markdown editors.
- Ensure traceability between requirements, design, testing, and release documentation for audit-readiness.
- Collaborate with the UX/UI team to create user-facing help content and tutorials for software modules and dashboards.
- Conduct peer reviews and ensure documentation consistency, version accuracy, and adherence to medical device software standards.
- Support internal and external regulatory audits by preparing and maintaining compliant documentation packages.
Education
- Bachelor’s degree in Technical Writing, Software Engineering, Biomedical Engineering, Computer Science, or a related technical discipline required.
- Master’s degree in Health Informatics, Regulatory Affairs, or Technical Communication preferred.
Required Skills and Experience
- 7+ years of experience developing software documentation within healthcare, medical device, or health technology (HealthTech) industries.
- Expertise in writing SOPs, SRS, SDS, validation protocols, and traceability matrices for regulated software environments.
- Deep understanding of healthcare industry standards and regulations, including:
- FDA 21 CFR Part 11 / 820
- ISO 13485 (Medical Device Quality Management System)
- IEC 62304 (Software Life Cycle Processes)
- ISO 14971 (Risk Management for Medical Devices)
- HIPAA / HITECH (Data Privacy and Security)
- Familiarity with AI/ML system documentation, data pipelines, and model validation for healthcare applications.
- Strong working knowledge of version control systems (Git, GitHub, Bitbucket), issue tracking tools (Jira), and document collaboration platforms (Confluence, SharePoint).
- Experience documenting API and SDK frameworks, RESTful and GraphQL endpoints, and microservice-based architectures.
- Understanding of cloud computing environments (AWS, Azure, GCP) and related compliance frameworks (FedRAMP, SOC 2, ISO 27001).
- Proficiency in authoring and publishing tools: Adobe FrameMaker, MadCap Flare, Markdown, Snagit, and Adobe Illustrator.
- Strong grasp of Agile/Scrum methodologies, including sprint-based documentation and cross-functional collaboration.
Excellent attention to detail, technical accuracy, and experience communicating with software engineers, regulatory teams, and clinical end users.
Preferred Qualifications
- Experience with AI-powered healthcare platforms, clinical software, or medical imaging systems.
- Familiarity with Good Automated Manufacturing Practice (GAMP 5) for validation documentation.
- Experience with electronic document management systems (eDMS) and quality management systems (QMS) for regulated industries.
- Working knowledge of HL7, FHIR, and DICOM interoperability standards for clinical data exchange.
- Experience producing interactive online help content and training materials for SaaS-based health software products.
- Technical writing certifications such as:
- Certified Medical Device Professional (AAMI/UL)
- Certified Professional Technical Communicator (CPTC)
- Regulatory Affairs Certification (RAC)
- Understanding of Good Documentation Practices (GDP) and 21 CFR Part 11 electronic records/e-signature compliance.
