Ramya Gumageri Email & Phone Number

Campbell, CA, US

Campbell, California, United States

New Jersey, United States

• Directed risk management activities, employing quantitative data analysis methods to evaluate and mitigate risks, enhancing product safety and compliance.
• Developed detailed documentation for Design History Files, integrating data analytics to streamline design and compliance processes.
• Collaborated with R&D to infuse data-driven risk management practices into product development cycles.
• Applied Python and R for detailed statistical analysis and risk assessments, supporting robust risk management documentation and compliance strategies.
• Leveraged SQL databases for managing and analyzing design and risk management data, facilitating more informed decision-making processes.
• Conducted comprehensive reviews of risk management strategies and documentation to ensure alignment with global standards and industry best practices.

Philadelphia, Pennsylvania, United States

• Packaging Design & Compliance:
• Spearheaded the development and implementation of innovative packaging solutions for class I, II, and III medical devices, focusing on patient safety and regulatory compliance.
• Conducted robust material selection and testing processes, adhering to ASTM and ISTA standards, to ensure packaging integrity and durability.
• Applied advanced CAD tools for 3D modeling and simulation of packaging designs, enhancing design efficiency and effectiveness.
• Led the design validation process, including creating protocols, conducting tests, and preparing validation reports that comply with ISO 11607-1 and -2 requirements.
• Collaborated with regulatory affairs to ensure packaging designs met global regulatory requirements, including FDA and EU MDR standards.