Resumen del Puesto: Diseña, desarrolla y optimiza procesos de manufactura para dispositivos médicos, liderando validaciones y mejorando la capacidad del proceso. Puntos Destacados: 1. Experiencia en ingeniería de procesos de dispositivos médicos 2. Liderazgo en validación y transferencia de procesos 3. Colaboración con equipos de calidad y normativos Descripción y detalle de las actividades **Key Responsibilities** * Design, develop, and optimize manufacturing processes for medical devices. * Lead process validation activities (IQ, OQ, PQ, and PPQ). * Characterize, scale, and strengthen processes using DOE, SPC, Six Sigma, and Lean principles. Perform process FMEA, root cause analysis, and problem\-solving to improve process capability (CpK* 1\.33\). * Coordinate process transfers from R\&D to production, ensuring manufacturability and regulatory compliance. * Collaborate with Quality and Regulatory teams to integrate process controls into the QMS and support regulatory submissions (e.g., 510(k)). * Implement continuous improvement initiatives focused on efficiency, cost reduction, and cycle time improvement. * Oversee qualification of equipment, tooling, and external suppliers. * Provide technical support for New Product Introduction (NPI) activities. * Mentor and support junior engineers, promoting best practices and knowledge transfer. Experiencia y requisitos **Experience** * Minimum of 3 years of experience in process engineering within the medical device industry. * Proven experience in process validation, technology transfer, and manufacturing scale\-up. * Direct involvement in New Product Introduction (NPI) projects. * Experience working in FDA\-regulated environments; Class II or III medical devices preferred. **Education** * Bachelor’s degree in Mechanical, Biomedical, Chemical Engineering, or a related field. * Master’s degree and/or Six Sigma Black Belt certification preferred. **Skills and Competencies** * Strong knowledge of Lean Manufacturing and Six Sigma methodologies. * Proficiency with DOE, SPC, and statistical analysis tools (e.g., Minitab). * Solid understanding of regulatory standards such as 21 CFR 820 and ISO 13485\. * **Advanced English (written and verbal) is required for technical communication with global teams and customers.** * Strong analytical and data\-driven problem\-solving skills. * Effective communication and collaboration skills in cross\-functional environments. * Technical leadership, mentoring capability, and ability to manage multiple projects in dynamic settings. Beneficios * Beneficios de acuerdo a la LFT * Seguro de vida * Transporte * Uniforme * Utilidades garantizadas * Caja de ahorro * Servicios medicos en planta * Comedor * seguro de vida * caja de ahorro * comedor * transporte * uniforme * gimnasio * seguro de gastos médicos **Número de vacantes** 1 **Área** Ingeniería **Contrato** Temporal **Modalidad** Presencial **Turno** Diurno **Jornada** Tiempo Completo **Horario*** Tiempo completo **Estudios** Carrera con título profesional **Inglés** Hablado: Avanzado, Escrito: Avanzado **Disponibilidad p. viajar** No