Merit Medical

Senior QA Design Transfer Engineer I

SUMMARY OF MINIMUM QUALIFICATIONS Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field. A minimum of eight (8) years of engineering experience. Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards. Advanced Engligh level TMV, MVP and validations experience (must) Working knowledge of statistical methodologies, quality control and manufacturing tools such as problem solving, root cause investigation, applied statistics, lean manufacturing, Six Sigma, etc., and project management experience. Knowledge of applicable regulatory agency regulations. Demonstrated computer skills, preferably spreadsheets, word processing, database, and other applicable software programs. PREFERRED QUALIFICATIONS Medical device experience or equivalent experience in a regulated industry. Experience with Minitab or JMP, Oracle. Passed ASQ Certified Quality Engineering exam. COMPETENCIES Interpersonal Skills Organization Written and Verbal Communication Teamwork Conflict Resolution Negotiation Problem Solving Decision Making COMMENTS Infectious Control Risk Category II: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.

Agosto 14 2026 en Tijuana

Engineer III

SUMMARY OF MINIMUM QUALIFICATIONS • Education equivalent to a Bachelor’s Degree in Engineering or technical field related to the department of assignment or industry with five 5 years previous related experience (title degree is required). • Advanced English level • Ability to apply analytical skills and scientific technical principles in problem solving and development. • Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs. • Strong interpersonal and organizational skills and the ability to work effectively as a team member. • Working knowledge of United States and international standards as applicable to the department. • Strong experience in material changes , including risk assessments, validations, and supporting documentation. • Experience leading low- to medium-impact projects , ensuring compliance with scope, timelines, and regulatory objectives. • Knowledge and experience in validations within the medical device industry , including the development and execution of IQ, OQ, and PQ protocols . • Experience developing and executing validation strategies for product, process, or material changes. • Knowledge of ISO 13485 requirements and practical application within a regulated environment. • Knowledge of European Medical Device Regulation (MDR) requirements, preferably with direct involvement in related projects. COMPETENCIES • Scientific techniques/evaluation/selection/application • Scientific variable analysis • Plans/surveys/structures/equipment • Supervisory assistance • Special projects/ECN's/prototype creation • NCMR causes/corrective actions/dispositions COMMENTS Infectious Control Risk Category II: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.

Agosto 13 2026 en Tijuana

Líder de Producción | (Turno Lunes a Jueves de 6:30 am a 6:30 pm)

RESUMEN DE LAS CUALIFICACIONES MÍNIMAS • Certificado de estudios de preparatoria. (Terminada) • Un mínimo de dos años de experiencia como Lider de Producción preferentemente fabricación en industria médica (requerido haber trabajado en ambientes controlados/cuartos limpios) • Demostrar lo siguiente: Cumplir los tiempos de ensamble programados mientras se cumplen las buenas prácticas de calidad. Habilidades interpersonales, capacidad para delegar y trabajar bien como parte del equipo de ensamble. Capacitar en las habilidades de ensamble y motivar a los trabajadores en el desarrollo del desempeño en equipo. Atención a los detalles y buenas habilidades de organización. Habilidades en la resolución de problemas y manejo de conflictos. Habilidades básicas en lectura, redacción y comprensión en inglés. Seguir instrucciones escritas y orales. Demostrar competencias informáticas, de preferencia en hojas de cálculo, procesamiento de textos, bases de datos y otros programas de software que aplican. COMPETENCIAS • Priorización de órdenes de trabajo. • Priorización del trabajo. • Proceso de ensamble/especificaciones de calidad. • Capacitación. • Presentación de informes de producción. • Resolución de problemas con el equipo/trabajo en equipo. • Normas/procesos de producción.

Agosto 12 2026 en Tijuana

Senior Platform Regulatory Specialist

MINIMUM QUALIFICATIONS • Bachelors degree in life sciences, engineering, regulatory affairs or a related discipline. • 8 years of progressive Regulatory Affairs experience in the medical device industry. • Advanced English level • Prior experience in medical industry • Prior experience with health authorities and regulatory agencies such as U.S. FDA, European Notified Bodies, and Health Canada. • Demonstrated general knowledge of global medical device regulations, and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc., Design Controls, reviewing and approving project plans, qualification protocols/reports. Modern computer skills. • Relevant regulatory certifications (e.g., RAC) strongly preferred. COMPETENCIES • Project management • Written and Verbal Communication • Attention to Detail • Continuous Improvement • Analytical Skills • Strategic leadership • Team development • Results oriented • Integrity • Organization COMMENTS Infectious Control Risk Category III: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.

Agosto 12 2026 en Tijuana

Operations Supervisor II

SUMMARY OF MINIMUM QUALIFICATIONS • Education and/or experience equivalent to a related Bachelor's Degree. • A minimum of three years of supervisory experience, preferably in a related manufacturing environment and demonstrated ability to supervise others in a team atmosphere. • Conversational English level (preferred) • Prior medical industry experience (clean room specifically) • Availability to work from Monday to Thursday from 6:30 am to 6:30 pm • Experience managing teams up to 80-100 people • Lean projects prior experience • At the Corporate site, if this position is on a Spanish-language line, bilingual (English/Spanish) basic speaking, reading and writing skills must be demonstrated. • Excellent analytical skills, including the ability to identify improvements in manufacturing methods and processes. • Ability to plan and organize production schedules to complete work orders on a timely basis and ensure that each work order is properly filled. • Ability to communicate effectively with others orally. • Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs. COMPETENCIES • Production supervisory process/work assigning/paperwork/clean room maintenance/quality standards • Personnel supervisory process/performance process/transfers/status changes/salary/ hiring/discipline • Product quality • Teamwork production/profitability goals • Train production method/safety/cleanliness standards COMMENTS Infectious Control Risk Category III: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.

Agosto 12 2026 en Tijuana

Quality Assurance Engineer II (Molding)

SUMMARY OF MINIMUM QUALIFICATIONS • Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field with three years quality engineering experience in medical devices. • Prior medical industry experience • Advanced English level • Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member. • Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards. • Proven ability to work effectively in a team environment through conflict resolution and negotiations. • Working knowledge of statistical methodologies, quality control and manufacturing tools, such as applied statistics, lean manufacturing, Six Sigma, etc. • Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs. PREFERRED QUALIFICATIONS • Medical device experience or equivalent experience in a regulated industry. • Experience handling non-conformances, deviations, investigations and CAPAs. • Experience in revieweing and approving validations for molded products. COMPETENCIES • Engineering techniques/evaluation/selection/application • Engineering variable analysis • Plans/surveys/structures/equipment • Supervisory assistance • Special projects/ECN's/prototype creation • NC causes/corrective actions/dispositions COMMENTS Infectious Control Risk Category II: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.

Agosto 12 2026 en Tijuana

Engineering Intern

SUMMARY OF MINIMUM QUALIFICATIONS • Currently studying (Engineering) or recently graduated • Prior experience in the medical industry • Experience in molding areas (preferrable) • Experience in time analysis and capacity calculation • Intermedium English level • Excellent organizational and interpersonal skills. • Ability to work well as a team member. • Knowledge of various tooling and testing equipment. • Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs. COMPETENCIES • Equipment assembly/installation • Record maintenance/computations/data plotting/simple curve and graph drawing • Test specimen preparation/general equipment operation • Computer skills COMMENTS Infectious Control Risk Category II: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.

Agosto 12 2026 en Tijuana

Técnico de Medición/Metrología

REQUISITOS Educación equivalente a un diploma de preparatoria con cinco años de experiencia laboral previa, incluyendo al menos un año de experiencia operando CMM. Conocimiento en el uso y métodos de operación de equipos CMM. Capacidad para leer e interpretar planos. Capacidad para seleccionar y utilizar el tipo adecuado de dispositivo de inspección, como calibradores, micrómetros, pasadores de calibración, calibradores de rosca, calibradores personalizados, comparadores, microscopios y CMMs. Excelentes habilidades analíticas y capacidad para resolver problemas técnicos simples. Excelentes habilidades organizacionales e interpersonales. Habilidades demostradas en el uso de computadoras, preferentemente hojas de cálculo, procesamiento de textos, bases de datos y otros programas de software aplicables. Capacidad para trabajar bien en equipo. Uso de equipos de medición y creación de rutinas en: CMM Contura con software CALYPSO 6.8 SmartScope Flash 500 con software MeasureMind 3D y ZONE3 Alto nivel de SPC (Control Estadístico de Procesos) Minitab , preferentemente a nivel avanzado (Normalidad, Gráfico de Corrida, Gráficos X-R, estudio de equivalencia, Pp & PpK CALIFICACIONES PREFERIDAS Inspección dimensional de componentes en un entorno de laboratorio. Conocimiento de acciones correctivas y preventivas (CAPA). Conocimiento previo de Minitab.

Agosto 12 2026 en Tijuana