Engineer Specialist - Manufacturing Improvement (Medical Devices)

Location: Tijuana, Baja California, Mexico

Company

hirify.global develops healthcare products and manufacturing processes focused on improving healthcare delivery and sustaining lives.

What you will do

• Integrate existing manufacturing processes transferred from other hirify.global sites.
• Develop and continuously improve mechanical device manufacturing processes and medical products.
• Lead Margin Improvement Projects, including feasibility analysis, project scope definition, savings validation, and implementation planning.
• Collaborate with Procurement on material and product quotations and lead Workshops, Kaizen, and VAVE events.
• Manage project schedules, costs, resources, workforce loading, and cross-functional follow-up.
• Develop and execute process validation activities, including IQ, SV, DOE, OQ, PQ, and TMV, before implementation.

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/FDA-regulated environments and under GMP requirements.
• Advanced English proficiency in written and verbal communication is required.

Nice to have

• Six Sigma experience.

Culture & Benefits

• Full-time employment.
• Culture centered on courage, trust, collaboration, ownership, and accountability.
• Work focused on healthcare delivery and the mission to save and sustain lives.