Sr. NPI Molding Engineer

Responsibilities

• Lead the development, characterization, optimization, and validation of injection molding processes for new product introductions and manufacturing transfers.
• Serve as the technical owner for molding process development activities, ensuring processes are designed for stability, repeatability, quality, and efficiency.
• Apply Scientific Molding methodologies to establish process windows, define process controls, and optimize molding performance.
• Design, execute, and analyze Design of Experiments (DOE), mold characterization studies, process capability studies, and engineering evaluations.
• Develop and execute process validation protocols and reports, including IQ, OQ, and PQ activities, in compliance with applicable quality and regulatory requirements.
• Analyze process and quality data using statistical tools to drive data-based decision-making and continuous process improvement.
• Lead mold trials, engineering runs, process qualifications, and scale-up activities from development through production release.
• Partner with Tooling, Quality, Manufacturing, Validation, Supply Chain, and Project Management teams to ensure successful project execution and product launches.
• Provide technical input during Design for Manufacturability (DFM) reviews, tooling design reviews, and product development activities.
• Identify, investigate, and resolve complex molding process issues using structured problem-solving methodologies and root cause analysis techniques.
• Develop and maintain technical documentation, including validation protocols, technical reports, process specifications, engineering studies, and change control documentation.
• Interface directly with external customers to review technical requirements, communicate project status, support development activities, and provide technical solutions throughout the NPI process.
• Support project planning, resource coordination, timeline development, and risk mitigation activities to ensure project objectives are achieved.
• Mentor and provide technical guidance to engineers, technicians, and manufacturing personnel on molding process development and Scientific Molding principles.

Requirements

• Bachelor's degree in Mechanical Engineering, Materials Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical discipline.
• Minimum of 7 years of experience in injection molding process development, process optimization, and validation within a manufacturing environment.
• Demonstrated expertise in Scientific Molding methodologies and their application to process development, troubleshooting, and validation.
• Intermediate to advanced English proficiency (B2+ or higher).
• Extensive experience conducting DOE studies, process characterization, process capability analysis, and statistical data interpretation.
• Strong knowledge of injection molding equipment, tooling, polymer processing, and engineering resins.
• Proven experience executing process validations (IQ/OQ/PQ) and developing technical documentation in regulated industries.
• Intermediate proficiency in SolidWorks for part, tooling, and manufacturability reviews.
• Intermediate to advanced proficiency in Minitab and statistical analysis techniques.
• Experience leading technical activities for New Product Introduction (NPI) projects and manufacturing transfers.
• Working knowledge of project management principles, project planning, scheduling, and cross-functional team coordination.
• Experience interacting directly with external customers and managing technical communications.
• Strong leadership, communication, analytical thinking, and problem-solving skills.
• Experience in the medical device industry or other highly regulated manufacturing environments.
• ‎ ‎
• Freudenberg Medical srl.

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