Process Engineer
hace 3 semanas
Descripción y detalle de las actividades
Responsible to provide support on engineering activities, projects, product, and processes transfer, contributing to the successful introduction of new products, improve production quality and performance.Providing technical support to asigned areas and contributing as team member to keep healty KPI’s. Take the ownership with process improvement projects and provide guideliness to other departments with technical information. RESPONSIBILITIES: - Analyze current process, identify improvement opportunities, create and excecute action plans using tools from lean manufacturing system (Ishikawa, 5 why’s, heijunka, 5’s, problem solving, kaizen events,) and six sigma (SPC,DOE,R&R, etc.). - Calculate line capacities, taktime, standar time, line balancing and manage layout updates. - Updating, creation and managment of SOP, WI, process flowcharts, templetes and requiere training for affected positions. - Monitor process KPI’s, provide technical knowledge, specifications, and criteria on assigned areas/processes and propose improvements based on data analysis. - Follow and ensure GMP, ISO 13458 and medical devices regulations. - Creation of process validation protocols (IOPDQ’s), execution of process/equipment validation (IQ’s-OQ’s) of existing protocols, perform Equipment Entry Qualification (EEQ) and engineering reports. - Support to new product introduction (NPI) activities, working hand in hand with engineering project team, executing functionality test, first article and blind test. - Design/buy fixtures and tools for process improvement, coordinate all related implementation activities such as test and documentation. - Participation during external audits as SME. - Work with multiple engineering/production local and international team members. - Participate on root cause analysis for NCR, CAPA and complaints with quality team.
Experiência y requisitos
- Bachelor’s Degree: Industrial, Mechatronic, Electrical, or related Engineering for medical/electronic devices. - English, spoken and written, capable to follow up a fluid conversation. - Minimum 3 years of experience on medical, electrical or related industries. - Troubleshooting, analytical and problem-solving skills & process control fundamental understanding. - Experiece with Microsoft Office (Visio,Excel,Power BI,Word, PPT). - Experience using lean manufacturing and/or six sigma tools - Experience with movement, time study and layout modifications to improve production lines. - Knowledge ISO 134885 and GMP. - Experience with quality system, NCR, NCMR, CAPA and Customer complaints. - Experience with fixtures and tool improvement.
**Número de vacantes** 1
**Área** Ingeniería
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario** Lunes a Jueves de 7am a 5:20pm y Viernes de 7am a 3pm
**Estudios** Carrera Profesional
**Inglés **Hablado: 80%, Escrito: 80%
**Sexo** Indistinto
**Disponibilidad p. viajar** Si
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