Process Engineer - Tijuana, México - Demant Operations, S.A. de C.V.
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.
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'sOQ'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.
- 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 problemsolving 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 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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