Engineer

4 weeks ago


Raleigh, North Carolina, United States Wipro Limited Full time

Responsible for Resolves competing constraints between interrelated functions (engineering purchasing manufacturing regulatory marketing etc.) required to deliver the product to market.

Defines protocols and conduct the necessary testing required to validate the safety and effectiveness of the design(s). Develops and maintains an effective and corroborative working relationship with internal and external development partners. Executes protocols and testing required to validate the safety and effectiveness of the design(s). Troubleshooting and problem solving efforts related to mechanical aspects of devices and associated systems/subsystems. Creates and communicates design/test plans tasks deliverables and status. Manages time and resources to meet committed schedule milestones. A demonstrated track record in Plastic component Design preferably medical devices or other highly regulated products. In depth knowledge of the regulatory environment for Design Develop and Manufacture of Medical products.

Knowledge of machinery to build prototypes handle variety of materials for prototypes and testing (metals plastics films etc.) set up engineering tests to validate new products and processes Demonstrated record of working with multiple vendors and suppliers.

Knowledge of standards such as IEC 60601 UL ANSI ASTM standards. Experience working with regulatory
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