Tijuana, Baja California- Beneficios de acuerdo a la LFT
Corporativo
Giro
Maquiladora (Export.)
Actividad principal
Manufactura de productos médicos.
Número de empleados
3000
Sitio Web corporativo
Descripción y detalle de las actividades
Essential duties and responsibilities
- Support new product tooling initiatives, tool changes, mold design, sourcing, and improvements to existing molds, focusing on manufacturability, cost reduction, quality, yield, and cycle time.
- Collaborate with Product Development, Manufacturing, Quality, Maintenance, Metrology/CT Scanning, and external suppliers to deliver tooling solutions and resolve technical issues.
- Lead tooling and molding projects, managing timelines, milestones, budgets, and SMART goals to ensure on-time completion.
- Lead tooling design reviews, develop tooling FMEAs, identify risks, and implement documented mitigation actions.
- Support phased validation of multi-cavity molds, including single-cavity activation and CT-scan dimensional confirmation before full-cavity release.
- Own CAPA activities from initiation through closure, including supplier corrective actions.
- Apply SPC, DOE, Six Sigma, IQ/OQ/PQ, Gage R&R, normality testing, and Ppk/Cpk capability analysis, using Minitab or similar statistical tools.
- Perform dimensional verification and print-to-model-to-part alignment using 3D scanning, metrology software (e.g., ZEISS INSPECT), and CT scanning.
- Develop tooling procedures and standard work instructions.
- Independently lead cross-functional teams, address technical challenges, and drive measurable improvements in cycle time, first-pass yield, quality, and cost.
- Maintain project trackers and provide proactive weekly status updates without manager follow-up.
- Communicate technical progress, results, and reports in English to cross-site and global stakeholders.
Experiencia y requisitos
Knowledge and Skills
- Strong knowledge of plastic part design for manufacturability, and plastic processing.
- Knowledge and experience with cold and hot runner high cavitation tools.
- Knowledge of mold manufacturing processes and their capabilities.
- Proficient in Solid works or similar.
- Working knowledge of statistical tools (e.g., Minitab) for DOE, SPC, Gage R&R, and process capability (Ppk/Cpk) analysis, including normality testing.
- Working knowledge of 3D scanning / CMM metrology software (e.g., ZEISS INSPECT) for dimensional verification against print and CAD models.
- Strong skills in project scheduling and SMART-goal based project management.
- Demonstrate problem analysis skills and provide solutions.
- Review and understand tool & product drawings, tolerance stack up, understanding molding processing documents, data collection and analysis and development of standard work instructions.
- Working proficiency in English (written and verbal) sufficient to prepare technical reports and deliver project updates to multi-site and global stakeholders.
- Strong self-management, accountability, and proactive communication — reliably reports project status without prompting.
Minimum Qualifications, Education and Experience
- BS in Mechanical Engineering or equivalent. In lieu of a degree a combination of training and experience will be considered.
- Min 3 - 5 yrs. experience in the Medical Device or Engineering Industry.
- Scientific molding/RJG molding knowledge/training.
- Mold Simulation experience.
- Experience with Silicone Molding.
- Experience with IQ/OQ/PQ process validation in an FDA 21 CFR 820 / ISO 13485-regulated environment preferred.
- Prior experience with mold or line insourcing, technology transfer, or multi-site project coordination is a strong plus.
Beneficios
Número de vacantes 1
Área Ingeniería
Contrato Permanente
Modalidad Presencial
Turno Diurno
Jornada Tiempo Completo
Horario
- Lunes a viernes
Estudios Carrera con título profesional
Inglés Hablado: Avanzado, Escrito: Avanzado
Disponibilidad p. viajar No