Computer Software Assurance (CSA) Engineer

About the role

Naviga AI and its 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. The role suits a proactive team player with a strong sense of ownership and a high work ethic who treats the product as their own.

Key responsibilities

• 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 the necessary technical inputs.

Required profile

• BSc in Computer Engineering or similar.
• Strong sense of ownership, high work ethic and excellent communication skills.
• Professional working proficiency in English.
• Remote setup with a 4-hour daily overlap with US East time zones.

Required skills

• Proven expertise in software QA and Product CSA execution.
• Writing high-level technical documentation for formal audits, specifically FDA.
• Nice to have: familiarity with FDA CSA guidance, 21 CFR Part 11/820, GxP or ISO 13485; experience with Python and modern AI agents.

What we offer

• A flexible, goal-oriented remote work environment.
• Unrestricted access to advanced AI productivity tools to accelerate your workflow.

To apply, send your resume by email to the company.