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Systems Verification & Validation Engineer - Beckman Coulter Diagnostics
Software Engineer
Design and execute verification and validation activities for diagnostic systems, ensuring compliance with GxP standards and delivering reliable, high‑quality products using MATLAB, C++ and robust risk‑analysis methods.
About the role
Key Responsibilities
- Develop and execute verification and validation test plans for new and updated diagnostic instruments.
- Collaborate with hardware, software, and regulatory teams to define test requirements and acceptance criteria.
- Perform risk assessments, root‑cause analysis, and corrective actions to meet GxP and FDA standards.
- Automate test procedures using MATLAB and C++ to improve efficiency and repeatability.
- Document test results, generate validation reports, and maintain traceability matrices throughout the product lifecycle.
Requirements
- Bachelor’s or higher in Engineering, Biomedical Engineering, or related field.
- 3+ years of experience in verification and validation of medical or diagnostic devices.
- Strong knowledge of GxP, FDA 21 CFR Part 820, and ISO 13485 compliance.
- Proficiency in MATLAB and C++ for test automation and data analysis.
- Excellent problem‑solving, communication, and cross‑functional collaboration skills.