Senior Staff Process Development Engineer - Molding

21 hours ago

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Dexcom

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Continuous Glucose Monitoring • Medical Devices • Diabetes • Decision Support • Data

10,000+ employees

Founded 1999

⚕️ Healthcare Insurance

🧬 Biotechnology

Description

• You will have extensive experience in injection molding manufacturing for high-volume Class II medical devices. • You will have experience in the defining the full injection molding work cell requirements, inclusive of tool and machine design and capabilities such a barrel and shot size with knowledge of their linkage to optimum product manufacturing performance. • You will develop detailed thermoplastic injection molding process capability and optimization studies, validations for robust, sustainable commercial production, and implement improvements to enhance yield, quality, and efficiency. • You will have strong data analytics and statistical analytics capabilities, inclusive of development of robust DOEs with strong linkage to CPK and PPK requirements. • You will support a range of programs from new product introductions and launches to scale up, on-market, and end of life management. • You will ensure adherence to design, quality, and safety standards, upholding GMP, FDA, and ISO guidelines. • You will collaborate closely with the Purchasing and Quality organizations to establish a rigorous supplier selection process, ensuring timely launches and sustained performance at the optimal cost profile. • You will provide technical insight in the development and implementation of on-market support initiatives, including a robust preventative maintenance management system, to maintain the yield, performance, and quality of products and subcomponents.

Requirements

• Bachelor’s degree in mechanical engineering, plastics engineering, or a related field and minimum 13 years related experience. • Profound knowledge of plastic injection molding processes, materials, tooling, and equipment, with the ability to troubleshoot complex issues and optimize processes. • Direct experience in injection molding manufacturing for high volume, Class II medical devices. • Experience in statistical process control (SPC) and use of software tools such as Minitab or JMP for data analysis. • Knowledgeable in SolidWorks and plastics flow simulation software/analysis. • Robust understanding of Plastic Part Design Guidelines, including dimensional tolerancing and GD&T Standards. • Demonstrated success in driving continuous improvement initiatives using LEAN, KAIZEN, and Six Sigma methodologies to significantly enhance process efficiency, reduce operational costs, and elevate product quality standards.

Benefits

• A full and comprehensive benefits program. • Access to career development through in-house learning programs and/or qualified tuition reimbursement. • An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.