Sustaining Engineer II
Teleflex
Position Summary
The Sustaining Engineer as part of the Interventional Business Unit’s Research & Development Team, the Sustaining Engineer II role provides engineering support to design and/or process alterations to existing products. Responsibilities will include scoping planning and executing design related deliverables and projects within the Teleflex Design Control process.
Principal Responsibilities Coordinate Design Change and Process Change activities. Develop design inputs and design outputs for changes to existing products or new distributed products. Provide R&D support for verification, qualification, and validation studies on existing products. Support risk management activities and risk management reviews on existing products. Provide R&D support for non-conformance investigations regarding component failures, finished goods failures, and product returns. Provide R&D support for customer complaints, including product/record investigation, health risk assessments, identification of CAPA’s, and report generation. Support regulatory approvals and responses to regulatory questions for existing products. Education / Experience Requirements Bachelor’s degree in a related engineering or other relevant field. 2+ years related experience working in a new product development, sustaining engineering, quality engineering or design assurance role. Specialized Skills / Other Requirements Bilingual (English/Spanish) communication and presentation skills (both written and spoken). Ability to work effectively with other product development team members. Proficiency in SAP and Agile (preferred). Strong communication and collaboration skills. Experience in the medical industry and knowledge of ISO 13485. The work site is located in Tecate, Baja California.
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