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Job Description
We have to look for Polymer background senior resource with Extrusion manufacturing process experience. Polymer skill by education (Chemical Engineering, Materials Science etc) & experience is required to do a good job in extrusion process.
Job Description:
▪ Senior Level Extrusion Engineer with 10+ years relevant polymer extrusion experience (Single Lumen and Micro-Extrusion Focus) ▪ Medical experience is preferred, but non-medical is also fine, as long as, candidate is technically strong in Polymer extrusion process.
▪ In-depth understanding of medical-grade polymers and their properties. (PCV, PFA, FEP, ETFE, CarboSil, PEEK, Bionate, PEBAX, Optim)
▪ Expertise in single lumen extrusion, core and single conductor extrusion, and micro-extrusion techniques.
▪ Proficiency in designing and optimizing extrusion dies and tooling, including the selection and pairing of tooling capable of meeting product outputs, analyzing defects, troubleshooting, and making recommendations for corrections to tooling, processes, or other related issues.
▪ Knowledge in Tip/Die Selection Process, Screw design requirements
▪ Demonstrated expertise in developing and optimizing extrusion processes for medical devices, including the establishment of processing windows and failure limits, standardizing process inputs through product bracketing, and visualizing outputs to determine key performance indicators (KPIs) for effective monitoring.
▪ Comprehensive knowledge of extrusion equipment, encompassing installation, troubleshooting, and resolution of technical issues.
▪ Proficiency in implementing Calibration, preventive maintenance (PM) and unplanned maintenance (UM) strategies to ensure optimal equipment performance and minimize downtime.
▪ Comprehensive knowledge of IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) validation processes.
▪ Familiarity with ISO 13485 standards and FDA regulations for medical devices.
▪ Knowledge of biocompatibility and sterilization processes, associated to extruded components.
▪ Experience in conducting risk assessments and implementing corrective actions, PFMEA.
▪ Proficiency in quality control methods and statistical process control (SPC).
▪ Serves as a SME for engineering or scientific interpretations and advice on significant matters
▪ Bachelors or Masters degree in Mechanical Engineering, Chemical Engineering, Materials Science, or a related field.
▪ Excellent communication and interpersonal skills. Strong analytical and critical thinking abilities.
Instructions
▪ Senior Level Extrusion Engineer with 10+ years relevant polymer extrusion experience (Single Lumen and Micro-Extrusion Focus) ▪ Medical experience is preferred, but non-medical is also fine, as long as, candidate is technically strong in Polymer extrusion process.
