Validation Engineer II

ICU Medical Inc; Tijuana; Presencial; MXN 360.000 - 480.000; Jornada completa

Descripción de la vacante

ICU Medical Inc. is seeking an experienced Process/Quality Engineer for our Baja California manufacturing site to ensure production aligns with design requirements for medical devices.

The role requires 3–5 years in manufacturing, a Bachelor’s degree in Engineering, and fluency in English and Spanish. You will develop process flow diagrams, validate production lines, write validation protocols, support audits, and drive continuous improvement in a regulated environment.

Formación

• Bachelor’s degree in Engineering required.
• 3–5 years of experience in a similar position.
• Manufacturing experience in the medical device industry.
• Ability to communicate in English and Spanish.

Responsabilidades

• Ensure production processes comply with established design requirements.
• Manage projects and activities with medium to high impact.
• Coordinate work teams for project management activities.
• Develop process flow diagrams and production layouts.
• Update or correct manufacturing and product procedures, as required.
• Perform product design testing and process validation.

Conocimientos

Process engineering

Quality systems

Project management

Statistical analysis

Documentation

Educación

Bachelor’s degree in Engineering

Herramientas

MS Office

AutoCAD

MS Project

Visio

Minitab

Descripción del empleo

• Ensure that production processes comply with established design requirements.
• Manage projects and activities with medium to high impact.
• Coordinate work teams for project management activities.
• Develop process flow diagrams and production process layouts.
• Update or correct manufacturing and product procedures, as required.
• Perform product design testing.
• Manage and participate in the validation of new production lines.
• Write and execute process validation protocols, equipment qualifications, material qualifications, and test methods, as well as ensure timely follow-up throughout the approval process.
• Participate in the development of master validation plans for various production lines.
• Maintain the validated state of equipment and production processes.
• Participate in the development and maintenance of pFMEA risk analyses.
• Replace obsolete equipment and fixtures with new equipment, including capital investment generation and analysis.
• Perform statistical capability analyses and use basic statistical tools.
• Understand and apply quality standards, policies, and procedures, including ISO 13485 and FDA requirements.
• Manage and implement continuous improvement tools.
• Provide support and follow-up for products undergoing transfer.
• Participate in internal and external quality audits.
• Request equipment repairs when necessary.
• Provide general supervision of the assigned area, including housekeeping, discipline, and 5S.
• Know and apply the policies and procedures of the Quality Management Systems (ISO 9001), ISO 13485, Environmental Management System (ISO 14001), Occupational Health and Safety Management System (OHSAS 18001), and any other systems required by the company for its operations.
• Work on special projects as assigned.
• Bachelor’s degree in Engineering required.
• 3–5 years of experience in a similar position.
• Manufacturing experience in the medical device industry.
• Thorough understanding and broad application of technical principles, theories, and concepts within the engineering field.
• Ability to clearly communicate ideas and concepts verbally and in writing in both Spanish and English.
• Critical thinking.
• Ability to organize resources and establish priorities.
• Ability to assign tasks and responsibilities.
• Basic knowledge of administration and management.
• Ability to follow procedures.
• Ability to interact with, develop, and motivate personnel.
• Proficiency in basic computer programs (MS Office, Microsoft Project, AutoCAD, Visio, Minitab).
• Ability to establish and maintain effective working relationships with employees from different departments.
• Ability to work with integrity and build trust.
• Intermediate problem-solving and analytical skills.
• Ability to critically review and interpret technical documentation.
• Ability to work accurately with attention to detail.
• Ability to manage multiple priorities and meet key deadlines under pressure through effective time-management skills.
• Works under general supervision, with direction provided in terms of broadly defined objectives and desired results.
• Continuously monitors the progress of activities or projects and evaluates results.
• Independently plans, schedules, conducts, or coordinates detailed phases of assigned tasks or projects.