• Coordinated and executed remediation efforts for the client to submit over a dozen technical files for EU MDR compliance• Authored reports to draw equivalency from existing validations to close gaps within product families• Lead a Peel Open study inclusive of all the clients sterile packaging materials to close the remaining gap of ISO 11607-1• Reviewed newly released standards and assessed the impact on the clients packaging • Executed package design testing at third-party locations• Coordinated with cross-functional team members weekly to reach common goals

• Supported the launch of an adult dose anti-psychotic drug for commercial use and child dose for clinical use• Drafted packaging design briefs and design descriptions• Developed packaging specifications for all primary packaging components• Managed relationship with external test lab to complete all packaging validation activities• Lead label alignment investigation at a contract packaging site to determine if label offsets were acceptable• Participated in an investigation to determine why packaging materials were not sealing correctly at the CMO

• Working knowledge of 21 CFR part 820 & EU MDR regulations, as well as the requirements of ISO 11607-1 & -2• Gained knowledge of a formal medical device design control process that includes the elements from the FDA Waterfall diagram, as well as risk management procedures and tools such as FMEA• Experience documenting packaging design inputs and creating a dFMEA for a sample medical device package• Built a library of common packaging types/materials, including rigid, FFS, and flexible materials, along with understanding their properties for design selection• Understanding of common sterilization modalities used for sterile barrier packaging systems: EO, gamma, E-beam, steam, and autoclave processes• Exposure to performance, stability, and process validation (IQ/OQ/PQ) requirements, the common test methods associated for compliance, and experience writing test plans and protocols for a sample medical device package• Toured manufacturing operations and learned firsthand from industry related suppliers in the areas of flexible films, converters, and thermoformers, as well as protective packaging, medical packaging third party test labs, and sterilization facilities • Experienced functional areas adjacent to packaging, including: Labeling, Regulatory Affairs, Clinical Evaluations, and Project Management