TEXAS

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Process 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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Education and Experience:

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• Bachelor of Science in Mechanical or Bio Engineering. 

• Minimum 5 years experience in catheter development 

• Authoritative figure in area of expertise. 

• Strong Solidworks skills. JMP or Minitab experience a plus. 

• Greenbelt or higher training is a plus. 

• Hands-on experience with a variety of catheter production equipment, such as: hot boxes, die-bonders, braiders, coil winders, laminators, ovens, UV adhesive light welders, laser welders, and others. 

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Skills and Responsibility:

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• Strong understanding of materials typical to catheter production: Pebax, Nylon, Polyurethanes, PEEK, PTFE, FEP, CA and UV adhesives, Stainless steel, NiTi, etc. 

• Strong overall knowledge of entire field of work, complex level engineering experience. 

• Familiar with technical literature and standards related to area of expertise. 

• Extensive hands-on experience. 

• Leadership skills. 

• Attention to detail, professional attitude, team player.

• Evaluate new product specifications, create process flow map, and timeline along with PM. 

• Evaluate and specify needed tooling, fixtures, and equipment to support product line. 

• Develop and design new process parameters, tooling, and methods for manufacturing. 

• Work ‘hands on’ with technicians to develop and define repeatable hand processes. 

• Create clear and concise DMR documentation to manufacture complex catheter assemblies. 

• Help train pilot production technicians, manufacturing operators, and transfer engineers in the assembly techniques, inspection methods and required documentation. 

• Optimize processes to meet manufacturing quality controls, build time, cost, yield targets. 

• Generate clear and concise work instructions, test methods, and visual standards. 

• Design and perform Process Characterization Study’s & DOE’s, support protocols and reports. 

• Have a firm understanding of validation strategy (IQ/OQ/PQ), support protocols and reports. 

• Maintain cleanliness of the work environment. 

• Mentor less experienced engineers. 

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Benefits and Allowances:

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• Relocation assistance is available.

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