onsite
Instrument Software Validation Analyst - NTT DATA Americas, Inc
Software Engineer
Lead validation of laboratory instrument software, ensuring compliance with regulatory standards through rigorous testing, documentation, and collaboration with cross‑functional teams.
About the role
Key Responsibilities
- Design, execute, and document validation test plans for instrument software in compliance with FDA, ISO 13485, and other regulatory requirements.
- Collaborate with software developers, QA engineers, and instrument manufacturers to define validation scope and acceptance criteria.
- Perform functional, performance, and security testing, analyze results, and prepare detailed validation reports.
- Maintain and update validation artifacts, including traceability matrices, risk assessments, and change control documentation.
- Support continuous improvement initiatives by identifying gaps in validation processes and recommending best practices.
Requirements
- 3+ years of experience in software validation within the medical device or laboratory instrument industry.
- Strong knowledge of regulatory frameworks (FDA 21 CFR Part 820, ISO 13485, IEC 62304).
- Proficiency in test management tools (e.g., JIRA, HP ALM) and scripting for automated test execution.
- Excellent analytical, documentation, and communication skills.
- Ability to work independently and collaboratively in a fast‑paced environment.