RHODE ISLAND

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Senior Staff Textile Development Engineer

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This company is dedicated to working collaboratively with their customers, taking their projects from rapid prototype into high colume production. Thier unparalleled technical expertise, proven experience and partnership with thier customers have allowed them to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Their primary capabilities include: nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. 

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Position Summary:

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In this position you will design and develop prototype medical textile based structures and processes to demonstrate feasibility for meeting customer needs. You will also develop products based on customer needs and specifications.

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Education and Experience:

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• BS or MS in Mechanical Engineering, Biomedical Engineering, Textile Engineering or equivalent.

• Minimum of 12 years developing textile solution for new products with focus on process development and validation related activities. Ideally covering braiding, knitting, weaving, and non-woven. 

• Strong mechanical aptitude for creating new capabilities is preferred. 

• Minimum of 3 years’ experience in a regulated industry. Medical device preferred. 

• Knowledge of Design/Process Excellence (Six Sigma black belt certified is a plus) preferred.

• Experience working with bio-absorbable polymer based implantable medical devices preferred. 

• Experience in the cardiovascular and/or orthopedic implantable medical device industry preferred.

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Skills and Responsibility:

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• Hands on aptitude to dive in and develop processes that are robust and transferable to manufacturing . Must be capable of handling multiple projects/tasks at the same time.

• Interact with customers, medical device engineers and sales team to understand the unmet needs and offer solutions.

• Select preliminary materials, manufacturing techniques in developing textile components and related value added processes. 

• Lead the selection and development of new technologies, equipment, capabilities and processes.

• Interact with outside vendors, suppliers, and consultants. 

• Provide technical support to sales, customers and operations. 

• Occasionally develop and execute design and process validation activities including IQ, OQ and PQ protocols, testing and reports.

• Support the creation of risk management and design control documents – per ISO 13485 including process flow charts, PFMEA, and control plans.

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 Please email a copy of your resume to blair.carter@searchrsa.com