Medical Device Manufacturing Improvement Engineer

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

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.