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