NPI Molding Engineer II
Cambus Medical - Freudenberg · Alajuela
Job description
Working at Freudenberg: We will wow your world! Responsibilities: Support the development, characterization, optimization, and validation of injection molding processes for new product introductions and manufacturing transfers. Execute process development activities, ensuring processes are designed for stability, repeatability, and quality under guidance from senior engineers. Apply Scientific Molding principles to support the definition of process windows and process control parameters. Participate in Design of Experiments (DOE), mold characterization studies, process capability studies, and engineering evaluations. Lead process validation activities, including IQ, OQ, and PQ execution and documentation in compliance with quality and regulatory requirements. Collect, analyze, and interpret process and quality data using statistical tools to support engineering decisions and continuous improvement. Lead mold trials, engineering runs, process qualifications, and scale-up activities from development to production release. Collaborate with Tooling, Quality, Manufacturing, Validation, Supply Chain, and Project Management teams to support successful project execution and product launches. Provide input during Design for Manufacturability (DFM) reviews, tooling discussions, and product development activities. Lead troubleshooting of molding process issues using structured problem-solving tools and root cause analysis techniques. Develop and maintain technical documentation, including validation records, process reports, engineering studies, and change control documentation. Support communication with external customers by providing technical updates and assisting in development activities during the NPI process. Contribute to project planning, timeline tracking, and risk identification activities to support achievement of project objectives. Participate in knowledge sharing and support training activities for technicians and production personnel on molding processes and best practices. Qualifications: Bachelor’s degree in Mechanical Engineering, Materials Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical field. Minimum of 2–5 years of experience in injection molding, manufacturing engineering, or process development within a manufacturing environment. Understanding of Scientific Molding principles and injection molding process fundamentals. Experience or exposure to DOE studies, process characterization, or statistical analysis (preferred but not required at advanced level). Knowledge of injection molding equipment, tooling, and polymer materials. Familiarity with process validation activities (IQ/OQ/PQ) is an advantage. Basic proficiency in SolidWorks for reviewing parts and tooling designs. Intermediate proficiency in Minitab or other data analysis tools is preferred. Exposure to NPI or manufacturing transfer activities is an advantage. Good communication skills and ability to work effectively in cross-functional teams. Intermediate to advanced English proficiency (B2 or higher). Strong willingness to learn, analytical thinking, and problem-solving mindset. Experience in medical device or regulated manufacturing environments. Training or exposure to Scientific Molding, RJG, or similar methodologies. Experience supporting mold trials or validation activities under supervision. knowledge of Lean Manufacturing or continuous improvement concepts. Familiarity with project tracking tools (MS Project, Smartsheet, Jira, etc.). Interest in developing toward a senior technical or leadership engineering role. The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. Freudenberg Medical srl.
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