**Senior Manufacturing Engineer – Single\-Use Medical Devices** **Job Summary** The Senior Manufacturing Engineer is responsible for developing and optimizing manufacturing processes for new products transferred into production. This role applies Lean principles to improve efficiency, reduce costs, and ensure safe, reliable, and compliant manufacturing operations within a regulated medical device environment. **Essential Duties \& Responsibilities** 1\. Process Development \& Documentation 2\. New Product Introduction (NPI) \& Manufacturing Transfer 3\. Continuous Improvement \& Lean Activities 4\. Compliance \& Quality System Responsibilities 5\. Production Support \& Troubleshooting **Required Qualifications** **Education \& Experience** * Bachelor’s degree in Mechanical, Manufacturing, Industrial, Electrical, or related Engineering field. * Minimum 5 years of production support and process development experience in the medical device industry. * Experience in new product introduction and/or manufacturing line transfer. * Familiarity with ISO 13485:2016, ISO 14971, and FDA QSR (21 CFR 820\). * English proficiency at 90% or above. **Required Skills \& Abilities** * Working knowledge of statistics; ability to perform statistical analysis using software (Minitab preferred). * Mechanical/electrical aptitude and understanding of basic machinery principles. * Ability to read and interpret engineering drawings and equipment schematics (electrical and pneumatic). * Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Visio). Tipo de puesto: Tiempo completo Sueldo: $1,800\.00 \- $2,200\.00 al día Beneficios: * Caja de ahorro * Estacionamiento de la empresa * Seguro de gastos médicos mayores * Servicio de comedor * Vales de despensa Experiencia: * ISO 13485: 3 años (Deseable) Idioma: * Inglés (Deseable) Lugar de trabajo: Empleo presencial