Engineer Specialist- Manufacturing Improvement

Baxter International Inc.; Tijuana; Sur place; MXN 600 000 - 1 000 000; Plein temps

Résumé du poste

Baxter International Inc. in Mexico seeks an experienced Mechanical/Manufacturing engineer to lead integration and improvement of device manufacturing processes. You will oversee projects from concept to validation, ensuring timeline, cost, and quality targets are met.

The role emphasizes cross-functional collaboration, process validation (IQ/SV/OQ/PQ/TMV), and implementing Lean and Six Sigma approaches in ISO/FDA-regulated GMP settings. Fluency in English is required.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• Minimum 5 years of related experience in manufacturing/engineering.
• Experience in ISO/FDA-regulated environments and GMP requirements.
• Strong problem-solving and leadership skills.
• Advanced English proficiency, written and spoken.

Responsabilités

• Lead integration of existing processes and development of manufacturing processes.
• Manage projects from concept to validation within timelines and budget.
• Identify opportunities for Margin Improvement Projects (MIP) and cost savings.
• Collaborate with Procurement for quotations and feasibility assessments.
• Lead workshops and Kaizen events related to process improvement.
• Develop and complete IQ/SV/OQ/PQ/TMV validation activities and update SOPs accordingly.

Connaissances

Project management

Lean practices

Six Sigma

GMP environments

Process validation

Formation

Bachelor's degree in Mechanical Engineering

Description du poste

This is whereyour work makes a difference.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Your Role at Baxter:

Responsible for the integration of existing processes (through transfers from other Baxter sites) and the development and continuous improvement of mechanical device manufacturing processes. May have full project ownership for significant projects within the specialized area.

Responsible for the development and improvement of medical products and manufacturing processes through comprehensive project management, ensuring business objectives are achieved in terms of timeline, cost, and quality.

What You'll Be Doing:

• Lead and manage Margin Improvement Projects (MIP) in accordance with the plant plan and departmental commitments.
• Ensure the timely and effective implementation of assigned projects while preventing any potential impact on manufacturing lines.
• Identify opportunities for potential MIP projects through self-initiated ideas related to direct materials used in device manufacturing, including assessing feasibility, project scope, and validating the financial savings associated with the project.
• Collaborate with the Procurement department to manage material and/or product quotations as part of the evaluation and feasibility assessment of generated ideas.
• Lead and manage Workshops, Kaizen, and/or VAVE events related to idea generation for MIP projects, identifying viable opportunities and providing follow-up with cross-functional teams on generated ideas.
• Lead project planning and may direct portions of smaller projects or segments of larger projects, including scheduling, cost monitoring, resource allocation, workforce loading, and related activities.
• Develop and complete process validation activities (IQ/SV/OQ/PQ/TMV) according to project plan timelines, along with the required updates to specifications, methods, processes, or procedures that are verified or, when applicable, validated in accordance with Standard Operating Procedures (SOPs) and QSR 820.75 requirements prior to implementation.
  

What You'll Bring:

• Bachelor's degree in Mechanical Engineering, Mechatronics Engineering, Electrical Engineering, Electromechanical Engineering, Systems Engineering, or a related field.
• Minimum of five (5) years of experience in a related position.
• Experience in problem-solving, project management and leadership, Lean practices, Six Sigma (preferred), and production line transfers. Experience working in ISO/FDA-regulated environments and under GMP requirements.
• Experience writing and executing process validations (IQ/SV/DOE/OQ/PQ).
• Advanced English proficiency, both written and verbal communication skills.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.