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.• Directed the creation of Risk Management files adhering to ISO 14971, significantly reducing product liability risks.• Conducted detailed risk assessments using quantitative analysis methods to evaluate and mitigate risks associated with medical device design and manufacturing processes.• Implemented GD&T principles in design specifications to ensure high precision and consistency in product manufacturing.• Developed and maintained comprehensive documentation for DHF, including risk management plans, reports, and FMEA analysis, ensuring compliance with regulatory standards.• Led the adaptation of design controls and processes to meet evolving standards such as EU MDR 2017/745, enhancing market access and compliance.• Collaborated with R&D and manufacturing teams to integrate risk management principles into product development, improving product safety and efficacy.

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.• Implemented continuous improvement strategies in packaging design and development processes, utilizing Six Sigma and lean manufacturing techniques to reduce costs and improve time-to-market.