Coordinates cross-functionally with marketing, clinical, sales, regulatory, operations (Internal/External) and shared services teams to define and document user needs, design inputs and outputs, design transfer and commercialization deliverables as per the design control procedure.
Document all new ideas for products and/or processes which should be assessed for intellectual property opportunity. Work with the legal team to file new patents and assess potential for infringement
Coordinates the development of concepts, prototypes, and corresponding test methods for rapid development cycles.
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Use appropriate quality tools and statistical techniques to collect and summarize data, draw conclusions with confidence, determine sample sizes, apply data distributions, identify relationships between variables, calculate reliability, design and analyze experiments, determine process and
Apply the most relevant and useful quality philosophies throughout Design Control and its related processes for both new product development and sustaining. Understand and manage work to minimize cost of quality throughout the product’s lifecycle.
Ensure compliance of all practices to the Quality Management System. Ensure comprehensive documentation is available, adequate records are produced, and change management is implemented.
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