Computer Software Assurance (CSA) Engineer

Product Computer Software Assurance CSA & Technical Writing We (Naviga AI and our US partner) are hiring a full-time, remote Computer Engineer to take ownership of Product Computer Software Assurance (CSA) and Technical Writing for FDA compliance. We need a proactive team player with a high work ethic who treats the product as their own. Core Requirements Degree: BSc in Computer Engineering or similar. Traits: Strong sense of ownership, high work ethic, and excellent communication skills for seamless team collaboration. Skills: Proven expertise in software QA, Product CSA execution, and writing high-level technical documentation for formal audits (specifically FDA). Language: Professional working proficiency in English. Availability: Remote setup requiring a 4-hour daily overlap with US East time zones. What You Will Do Lead the technical writing and system configuration documentation required for FDA (Food and Drug Administration) approvals. Implement risk-based CSA methodologies and design test scenarios with lean, audit-ready documentation. Collaborate closely with cross-functional engineering teams to gather necessary technical inputs seamlessly. Nice-to-Haves Familiarity with FDA CSA guidance, 21 CFR Part 11/820, GxP, or ISO 13485. Experience with Python, modern AI agents. What We Offer Flexible, goal-oriented remote work environment. Unrestricted access to advanced AI productivity tools to accelerate your workflow. To Apply: Please send your resume to info@navigaai.com