Computer Software Assurance (CSA) Engineer (2 Open Positions)

Computer Software Assurance (CSA) Engineer (2 Open Positions)

We (NavigaAI and our US-based partner) are currently looking for two full-time, remote Computer Software Assurance (CSA) Engineers.

In this role, you will ensure that our software applications and development tools for medical systems meet the highest quality, regulatory, and FDA compliance standards.

Core Requirements (Must-Haves)

• Proven expertise in software quality, non-product software validation (Tool Validation), and assurance principles for regulated, safety-critical medical environments.
• Professional working proficiency in English (all documentation and cross-border communication will be in English) and Turkish.
• Ability to thrive in an independent, remote work environment, requiring a 4 hour daily overlap with US East time zones (including daily sync meetings).

What You Will Do

• Tool Validation & Compliance: Validate software development tools (e.g., AI frameworks, packages, tools, internal CI/CD pipelines) to prove they are safe, reliable, and capable of supporting FDA-approved medical devices.
• Risk-Based CSA Execution: Implement FDA-aligned risk-based CSA methodologies. You will analyze tool usage and failure modes (e.g., data corruption), classify risks, and determine the right test strategy (scripted robustness tests for high-risk; scenario-based/exploratory for low-risk).
• Lean Documentation: Design test scenarios (functional, integration, regression), document validation activities, and record evidence with full traceability—without creating unnecessary documentation overhead.
• Product Validation Support: Act as a secondary support pillar for the validation of the end-product itself.
• Collaboration: Collaborate cross-functional stakeholders (product, engineering, and clinical teams) on software assurance best practices, audit trails, and electronic signatures.

What We Are Looking For

• Technical background in software QA, software testing, and software engineering.
• Strong ability to produce detailed, high-quality technical documentation (experience in R&D or heavily documented technical projects is a plus).
• Solid understanding of databases, data integrity, and secure data lifecycle management.
• Bachelor’s degree in Computer Science or a related field.
• Familiarity with relevant industry standards and regulations (e.g., FDA guidance on CSA, 21 CFR Part 11/820, GxP, ISO 13485, IEC 62304).
• Familiarity with Python, modern AI agents, React is advantageous.

What We Offer

• Flexible Remote Work: A fully remote environment managed by weekly goals rather than strict micro-management.
• Modern Tooling: Unrestricted access to advanced AI productivity tools (e.g., premium GPT) to accelerate your workflow.

To Apply: Please send your resume to [email protected]