Job Title: Project Engineer
Job Description: Design and develop catheter products for biomedical applications with in-house extrusion expertise as requested by customers. Work under the direction of the Manufacturing Manager to meet customer requirements. Communicate with customers regarding device specifications and performance during the design process while considering project costs. Prepare project time lines with regular updates. Develop and propose specifications for components of various medical devices and create the manufacturing bill of materials for the project. Use service-oriented architecture on assigned projects and order components on time to meet project time lines.
Design, develop and manufacture tooling, fixtures, and equipment for manufacturing projects, as necessary. Use equipment and tools to establish processes and to manufacture products. Document research and development processes in lab notebooks, work orders, or through other methods. Design and develop test equipment, as necessary. Create new and/or revise existing manufacturing documentation for improved materials, components, and/or processes, for example, manufacturing process instructions, work orders and component specifications. Design and/or conduct experiments and process characterizations to determine optimal process parameters, as directed. Participate in technical reviews and receive process approval from the Process Development Manager. Provide support to and work with managers in obtaining optimal process parameters and for the assembly of products. Train technicians, assemblers, and other manufacturing personnel on the processes of various projects and building prototypes. Conduct GMP (Good Manufacturing Practice) on all projects. Develop process validation protocols, equipment qualification documents (IQ/OQ/PQ), and process capability studies (e.g. CpK, PpK, etc.), analyze data, and author reports, as directed.
Minimum Qualifications: Bachelor’s degree in biomedical engineering, or mechanical engineering and one year of experience as a manufacturing operator or a project engineer.
Job Location: Santa Cruz, CA
Contact Us: Send resume to Duke Empirical, ATTN: B. Collazo, 2829 Mission St, Santa Cruz, CA 95060