I have extensive experience in design validation, including developing and executing test plans, conducting failure analysis, and ensuring compliance with industry standards. My approach involves a combination of simulation, physical testing, and statistical analysis to validate product designs. I have worked on projects where I collaborated with cross-functional teams to identify potential design flaws early in the development cycle, reducing time-to-market and improving product reliability. My expertise also includes using tools like FMEA and DOE to systematically evaluate and mitigate risks.

To ensure compliance with regulatory and customer requirements, I start by thoroughly understanding the applicable standards and specifications. I then develop a comprehensive validation plan that includes both regulatory testing and customer-specific use cases. Throughout the process, I maintain detailed documentation to demonstrate compliance. I also engage with stakeholders to gather feedback and make necessary adjustments. By integrating these requirements into the validation process early on, I ensure that the final product not only meets but often exceeds expectations.

I am proficient in using tools like MATLAB, LabVIEW, and ANSYS for simulation and data analysis, as well as CAD software for design review. These tools have been instrumental in automating test processes, analyzing complex data sets, and predicting product performance under various conditions. For example, using ANSYS, I was able to simulate stress and thermal conditions, which helped in identifying potential failure points before physical testing. This not only saved time but also reduced costs associated with prototyping and testing.

One challenging project involved validating a medical device with stringent regulatory requirements. The device had to undergo extensive biocompatibility and durability testing. The challenge was the tight deadline and the need for high precision. I addressed this by optimizing the test plan, prioritizing critical tests, and leveraging automation tools to speed up data collection. I also collaborated closely with the regulatory team to ensure all documentation was accurate and complete. Despite the challenges, we successfully validated the device on time and received regulatory approval without any major issues.

When discrepancies or failures are identified, I first conduct a root cause analysis to understand the underlying issues. I then document the findings and work with the design and engineering teams to develop corrective actions. Communication is key; I ensure all stakeholders are informed and involved in the resolution process. Once corrective measures are implemented, I re-run the necessary tests to confirm the issue is resolved. This systematic approach ensures that the final product is robust and reliable, meeting all required specifications and standards.