Baxter International Inc.Senior R&D Engineer
Sep. 2021 - Oct. 2023Malta- Technical Lead for a labelling standardization & Geo-Expansion project which aimed at reviewing, updating and implementing 60+ medical devices' labels as per ISO 15223 and 20417 in close cooperation with Regulatory department.
- Responsible for manufacturing related activities between various manufacturing plants and external suppliers to gather the raw material needed for all the R&D builds to be used for verification testing on 15+ medical devices and to schedule process validations and design transfers in time for product launch. - Define Design Inputs, convert them into Design Outputs and perform Verification & Validation activities on the final product
- Develop and execute testing studies to assess product conformance according to ISO standards for marketed and new products (ISO 13485, 1135, 8536 etc).
- Support MDR & FDA submissions.