Manufacturing Engineer 3

Intuitive; Mexicali; On-site; MXN 450,000 - 800,000; Full time

Job summary

Intuitive busca un profesional con experiencia en manufactura de dispositivos médicos para liderar iniciativas de Lean manufacturing y mejora continua a nivel site. Serás el impulsor de la implementación de herramientas Lean y de proyectos de mejora.

Deberás entrenar al personal, gestionar ECOs y asegurar la conformidad con el sistema de calidad. Responsable de optimizar procesos, evaluar diseños para manufacturabilidad y colaborar con proveedores para resolver problemas de calidad, manteniendo

Qualifications

• Experiencia en manufactura de dispositivos médicos y mejora continua.
• Capacidad para liderar proyectos y entrenar a equipos.
• Conocimiento de ECOs, MPIs y procedimientos del sistema de calidad.

Responsibilities

• Encargarse de la manufactura de tooling/fixtures y equipos de fabricación.
• Evaluar diseños de mecanismos para confiabilidad y manufacturabilidad; proponer cambios.
• Aprobar liberaciones de diseño hacia la manufactura y revisar documentación técnica.
• Gestionar ECOs desde perspectivas de manufactura y campo.
• Desarrollar y mantener el cumplimiento del sistema de calidad.
• Colaborar en la selección de proveedores de partes mecánicas y resolver problemas de calidad.
• Mantener, revisar y actualizar MPIs/Procedimientos del Sistema de Calidad.
• Proporcionar retroalimentación de rendimiento a producción y lograr mejoras en seguridad, calidad y costos.
• Participar en iniciativas de mejora de calidad y diseño/ documentación de tooling.

Skills

Lean manufacturing

leadership

training

problem solving

project management

continuous improvement

quality system

Job description

Descripción del empleo

Primary Function of Position.

Contribute your leadership and technical skills in the areas of manufacturing process technologies, problem-solving, training, and project management in a growing medical device company. In this key role, you will be the driving force behind Lean tool implementation and continuous improvement projects site wide. Your combination of training, motivational skills, analytical problem-solving ability, and passion for Lean manufacturing will be just the right fit for the manufacturing environment of precision instruments for minimally invasive robotic surgery.

Essential Job Duties.

• Manufacturing responsibility for tooling/fixtures, manufacturing equipment, and design improvements in production.
• Evaluate and challenge mechanism designs for reliability, functionality, and manufacturability. Provide suggested change proposals.
• Approve design releases to manufacturing, review engineering documentation, and provide vendor and in-house DFM inputs.
• Review/approve and determine the impact of ECOs from manufacturing and field perspectives.
• Take responsibility for developing and maintaining compliance with the quality system.
• Evaluate and help in the selection of suppliers for mechanical parts if required. Help resolve supplier quality issues.
• Update and revise Manufacturing Process Instructions (MPIs) to ensure accuracy and completeness.
• Address line support issues as they arise.
• Document and report any variances, problems, issues, or concerns on all aspects of the manufacturing process.
• Provide production personnel with expectations and performance feedback regularly in the production process.
• Drive improvements in safety, quality, production, and cost.
• Understand, train personnel, and enforce strict adherence to the applicable Department Operating Procedures (DOPs) and Standard Operating Procedures (SOPs) of the Quality System.
• Maintain up-to-date and accessible training records for MPIs and Quality System documents.
• Assist in setting and attaining quarterly and annual production goals.
• Learn and enforce company safety policies and practices.
• Review and disposition of discrepant material in the manufacturing line.
• Implement corrective actions to prevent recurrences.
• Active participant in quality improvement initiatives, providing feedback to find the root cause and problem-solving.
• Design and documentation responsibilities for custom and standard production tooling/fixtures.
• Process and part design/documentation duties for cost reduction programs.
• Execute and present Equipment Qualification Reports
• Define Preventive Maintenance, calibration and troubleshooting procedures.
• Define Startup Instructions of Equipment
• Provide feedback for operation of equipment for Manufacturing Process Instructions
• Transfer new manufacturing lines or equipment, interface with logistics for movement of equipment.
• Participate in continuous improvement projects related to manufacturing equipment.
• Perform Hardware and Software updates of equipment.
• Generate and Submit ECOs
• Modify and improve Fixtures.
• Interface with external vendors for service, calibration or purchasing of equipment.