Sr. Materials Engineer – Extrusion
$108,800–$163,200 year
On-site · Beverly, Massachusetts, United States
Job Summary
Senior Materials Engineer – Extrusion responsible for process design, development, and material selection to support new and improved extruded catheter sub-assemblies; perform polymer rheological characterization to shorten material selection and benchmark melt properties; coordinate mechanical and chemical property testing of polymer; install and validate IQ/OQ/PQ on new equipment and processes; execute Test Method Validation (TMV) for extrusion to ensure accuracy, repeatability, and regulatory compliance; review new applications to leverage existing technologies; provide process engineering support for development runs and investigate potential manufacturing problems; present extrusion concerns at Material Review Board meetings; apply Lean Six Sigma methods (DOE, SPC, FMEA, QSR, DMAIC) to drive production improvements; perform data analysis with Minitab; author technical specifications under ISO and cGMP document control; collaborate with Quality and overseas customers on process changes; and participate in continuous improvement within a medical device manufacturing context.
Required Qualifications
- Master’s degree in Mechanical, Materials, or Plastics Engineering or related field
- two (2) years of experience as a materials or extrusion process engineer or related occupation
- Extrusion process and project engineering
- ISO 9001, ISO 13485, and cGMP
- DOE, SPC, FMEA, QSR, IQ/OQ/PQ, and technical writing
- Test Method Validation
- polymer rheological characterization
- Mechanical & Chemical property testing of polymer
- DMAIC process, root cause analysis, and implementation of corrective action
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