Manufacturing Improvement Engineer Specialist

Zvh; Tijuana; On-site; MXN 600,000 - 900,000; Full time

Job summary

Baxter is seeking a Senior Mechanical Engineer to lead the development and improvement of medical device manufacturing processes. You will manage projects from concept to validation, aligning timeline, cost, and quality with business goals.

The role requires five years in related positions, strong project leadership, and experience in regulated environments. English proficiency is essential, and you will collaborate across functions to drive cost savings and process validation per SOPs.

Qualifications

• Bachelor's degree in Mechanical Engineering or 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 in ISO/FDA-regulated environments and GMP requirements.
• Experience writing and executing process validations (IQ/SV/DOE/OQ/PQ).
• Advanced English proficiency, both written and verbal communication skills.

Responsibilities

• 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 SOPs and QSR 820.75 requirements prior to implementation.

Skills

Lean

Six Sigma

Project management

Problem solving

English (Advanced)

Education

Bachelor's degree in Mechanical Engineering

Job description

This is where your 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.

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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.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.