Medical device product Development Engineer
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I am a detail-oriented and solutions-driven Plastic processing Engineer (Injection Molding and Extrusion process) with 14 years of experience in plastic part design, mold and die development, and process optimization. My expertise spans tool design validation, material selection, cycle time reduction, process validation, and troubleshooting molding and extrusion part-related defects to ensure consistent product quality and manufacturing efficiency.
I have worked closely with cross-functional teams in food packaging industry and medical device to launch new products and implement lean manufacturing strategies. With a strong background in CAD and scientific molding principles and quality systems (ISO 13485 & ISO 9001), I focus on delivering robust, cost-effective solutions in high-quality production environments.
I’m passionate about continuous improvement, automation, and leveraging data to drive productivity and innovation in injection molding and extrusion process operations.
Injection molding and Extrusion molding Product development In-charge for manufacturing class III & IV medical devices and managing ISO 7 cleanroom.
Leading thermoplastic and elastomer material Injection Molding projects for medical device manufacturing operations.
Involves - New Project development, Process troubleshooting, and reducing quality loss. Experienced with virgin/compounded Injection molding materials, such as Polyethylene, PEBAX, polypropylene, PETG, ABS,
Polycarbonate, with different property enhancing additives. etc. with the hands-on experience with Injection molding machines like: Milacron, Arburg, Engel, BOY, BabyPlast, etc.
Leading single-lumen and millilumen medical extrusion tubing projects. Experienced with virgin/compounded resin materials, such as: Polyethylene, Polyamide, Pebax, Polyurethane, Fluorinated Ethylene Propylene.
Responsible for making purchase decisions for manufacturing line or capital equipment, equipment commissioning/FAT and installation qualification, process qualification, and estimating budget requirements for future projects.
Lead Process Validation activities starting from creating a validation plan, executing validation activities and perform and submit test validation reports.
Support tool implementation activities like tool installation, qualifications, and validation.
Review and Approve Quality documents, Create ECO’s (Engineering change Orders).
Conduct process risk analysis (PFMEA) and Design Risk Analysis (DFMEA) for products under development and implement process controls to drive risk mitigations
Handling of various polymer characterizations testing equipment to analyze and inspect polymer materials for R&D and Production application.
Leading continues improvement process activities to improve production capacity and focus on future scope of work.
Lead and manage medium to large size multimillion dollars projects.
Experienced with Production and quality management tools like eQMS, Windchill, MES, PowerBI, CoPilot, etc.