{"id":2387149,"url":"https://alion.io/job/medline-sr-engineer-verification-validation","title":"Sr Engineer Verification & Validation","company":{"id":7482,"name":"Medline","domain":"medline.com","url":"https://alion.io/company/medline","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":82,"open_postings":95,"ghost_share":0,"stale_share":0.695,"repost_share":0.011,"time_to_fill_p50_days":23,"computed_at":"2026-10-14T06:34:16Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Nuevo Laredo, Mexico"],"countries":["MX"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":46000,"max_usd":105000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":6708},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"AutoCAD","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-10-12T20:24:42Z","employer_posted_date":"2026-10-12","last_verified_at":"2026-10-14T20:35:25Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Job Description\nObjetivo General:\nResponsable de Diseñar, Desarrollar, Ejecutar, Documentar e Implementar todas las validaciones relacionadas a Software, Maquinaria, Procesos Nuevos e Introducción de nuevos productos requeridos por la planta para todas las divisiones de Medline. Siempre en cumplimiento a los estándares y normativas legales requeridas para habilitar venta de productos de Medline Industries, Inc. y Estableciendo que los métodos de proceso sean óptimos para producción y aseguramiento de la Calidad.\nResponsabilidades:\nResponsable de que los protocolos generados cumplan los lineamientos de la ISO-13485, ISO-11607, FDA CFR 21.820, CFR21.11 y procedimientos de Medline Industries, Inc.\nResponsable que cada Validación / Estudio de ingeniería se diseñe en un protocolo, se presente y apruebe por la Alta Dirección de la empresa, y se ejecute de acuerdo a lo planeado.\nResponsable de que cada validación / estudio de ingeniería concluya con un diseño e implementación de procedimiento, instrucción de trabajo, set-up, método de inspección, su registro e impulsar la implementación de seguridad del operador cualificado del proceso a calificar.\nElaborar e interpretar análisis estadísticos [CPK, PPK, GR&R, ANOVA entre otros] para toma de decisiones.\nResponsable del diseño de Productos y determinación de estado de validado a nivel Finish Good.\nIntroducir Nuevos Procesos y Productos.\nUsar de herramientas y metodologías de MKOS, Lean Manufacturing, Herramientas de Calidad entre otros, para fines de investigación, Solución de Problemas y Mejora.\nImplementar eventos Kaizen, programas de MKOS y CAPAS.\nElaborar de MCORs necesarios para liberación de productos/procesos/maquinaria nueva o modificada.\nMonitorear y mejorar los resultados costos, eficiencia, calidad y seguridad.\nResponsable de Implementación de proyectos de ahorro y de cumplimiento.\nAtender y Responder Auditorias.\nDesarrollar personal.\nExperiencia / conocimientos tecnicos.\nExperiencia mínima de 4 años en industria Medica/Quirúrgica o Farmacéutica. \nBilingüe (inglés - español) 70% intermedio / avanzado\nManejo de Minitab, AutoCAD, AS400, M-Power, Pack Draw, Macros, Adobe, Microsoft office (Project, Excel, Word, Power Point, Outlook) (avanzado).\nExperiencia como auditor interno de calidad en ISO 13485.\nConocimiento básico de programación de sistemas computacionales (Deseable).\nCompetencias / Softskills\nConocimiento en la Ley de USA FDA Code Federal Regulation parte 11 y parte 820.\nConocimiento en ISO-13485 Medical Devices Quality Management Systems\nConocimiento en ISO-11607 Packaging for terminally sterilized medical devices.\nConocimiento en ISO-5356 Anaesthetic and respiratory equipment\nConocimiento en estándares ISTA 3A, ASTM 1980, ASTM F1886/F1886M, ASTM 2551, ASTM 2559, ASTM F1140, ASTM F88/F88M, ASTM F1929, ASTM F2096, ASTM F3039.\nConocimiento en mecánica, hidráulica, neumática, electricidad, electrónica, termodinámica y termoformado intermedio / avanzado.\nConocimiento y habilidad de implementación en Lean Manufacturing, Herramientas de Solución de Problemas y Calidad, Core Tools, 6 Sigma, Metodología de MKOS.3.3 Formacion academica\nIngeniería terminada. Preferente en Bio-médica, Química, Mecánica, Eléctrica, Mecatrónica, Industrial.\nDeseable Maestría/certificaciones relacionados a Calidad o estadística.\nMedline Industries, LP is an equal opportunity employer. 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