Manufacturing Improvement Engineer Specialist (Medical Devices)

Location: Tijuana, Baja California, Mexico; onsite manufacturing role

Company

Healthcare manufacturer focused on developing medical products and improving healthcare delivery.

What you will do

• Integrate transferred manufacturing processes from other sites and develop mechanical device manufacturing processes.
• Lead Margin Improvement Projects, including feasibility analysis, project scope definition, financial savings validation, and implementation planning.
• Identify improvement opportunities involving direct materials and collaborate with Procurement on quotations and feasibility assessments.
• Lead Workshops, Kaizen, and VAVE events and coordinate follow-up with cross-functional teams.
• Manage project schedules, costs, resources, workforce loading, and implementation risks.
• Develop and execute process validation activities, including IQ, SV, OQ, PQ, and TMV, with updates to specifications, methods, processes, and procedures.

Requirements

• Bachelor’s degree in Mechanical, Mechatronics, Electrical, Electromechanical, Systems Engineering, or a related field.
• At least five years of experience in a related position.
• Experience with problem-solving, project management, leadership, Lean practices, and production line transfers.
• Experience writing and executing process validations, including IQ, SV, DOE, OQ, and PQ.
• Experience in ISO- and FDA-regulated environments and under GMP requirements.
• Advanced English proficiency in written and verbal communication.

Nice to have

• Six Sigma experience.

Culture & Benefits

• Mission-driven work focused on saving and sustaining lives.
• Culture of courage, trust, collaboration, ownership, and accountability.
• Focus on efficient operations and meaningful impact in healthcare.