Tijuana, Baja California- Beneficios de acuerdo a la LFT
- seguro de vida
- bonos anuales
- caja de ahorro
- comedor
- transporte
- seguro de gastos médicos
- plan de indexación
Corporativo
Giro
Farmacéutica
Actividad principal
Equipo medico
Número de empleados
400
Sitio Web corporativo
Descripción y detalle de las actividades
Essential Job Functions and Responsibilities
- Drive process-product improvement activities to promote product quality, overall manufacturing cost, efficiency and manufacturability using statistical techniques, lean manufacturing tools, Six Sigma, tool & fixture design, and DOE for process and equipment
- Resolve technical issues and provide production support to quickly address production issues in a high-volume low mixed manufacturing environment to ensure product supply is not impacted
- Implement continuous improvement projects related to first pass yield, cycle time reduction, product reliability, capacity improvements, and cost reduction
- Provides technical leadership and Design for Manufacturability input to product development teams
- Work closely with R&D to release of new products
- Responsible for developing engineering-manufacturing documentation (Work instructions, procedures, BOMs, Routings, PFMEA, Rework instructions, drawings, etc.)
- Responsible for process-equipment validation (IQ/OQ/PQ/MSA activities)
- Work with PMO team to adhere with project schedules and to shorten timelines.
- Initiate corrective and preventive action in accordance with company CAPA procedure
- Engage with suppliers to ensure project objectives are met and that product performance meets customer and quality requirements
- Support Nonconformance (NC) processes by leading investigations, defining rework or repair instructions, and providing data-driven disposition justifications in compliance with quality system requirements
- Maintain engineering performance metrics, including Scrap, First Pass Yield, and Rolled Throughput Yield (RTY); analyze trends and drive corrective actions to improve key process indicators
- Lead engineering projects from concept through implementation, ensuring timely delivery, budget adherence, and alignment with business priorities
- Provide regular status updates to stakeholders
- Conduct ROI and cost-benefit analyses to justify project investments and measure effectiveness
Experiencia y requisitos
The Senior Manufacturing Engineer will act as an individual contributor within the Manufacturing Engineering team to develop and improve upon the disposables/consumable products utilized within the Tablo System. This person will interact with both internal resources, as well as external suppliers and Contract Manufactures (CM’s) to develop and transfer new products into production and improving sustaining products in accordance with established policies, goals and objectives. Good communication, interpersonal skills and analytical skills are needed in this role.
Required Qualifications
- B.S. in Industrial Engineering or similar technical field.
- 5+ years of experience in the manufacturing/ design of medical products, with a strong background in the manufacturing & development of disposable/single use medical devices.
- Experience with high volume manufacturing assembly processes.
- Strong knowledge of FDA quality system regulations, GMP, and ISO 13485 requirements.
- Strong track record in design, testing, and manufacturing process development.
- Strong analytical and technical skill set based on engineering analysis fundamentals.
- Demonstrated ability to find creative ways to meet tight timelines.
- Experience managing engineering projects.
- NPI experience.
- Proficient in Microsoft Office Suites, Minitab, Visio, AutoCAD and SolidWorks.
- Must be able to communicate fluently in both written and spoken English.
Desired Qualifications
- Green Belt certified
- Ability to multi-task and manage multiple assignments in a timely manner.
- S. in Industrial Engineering (or similar).
- Experience with extrusion, ultrasonic welding, tube set manufacturing, and injection molding technologies.
- Design for manufacturability and cost optimization experience.
- SolidWorks experience.
Beneficios
Número de vacantes 1
Área Producción/Manufactura
Contrato Permanente
Modalidad Híbrido
Turno Diurno
Jornada Tiempo Completo
Estudios Carrera con título profesional
Inglés Hablado: Avanzado, Escrito: Avanzado
Disponibilidad p. viajar No