Spec, MIP-Engineering (Medical Devices)

Location: Tijuana, Baja California, Mexico; onsite

Company

Medical technology company focused on developing healthcare products and solutions that help save and sustain lives.

What you will do

• Lead margin improvement projects in line with the site MIP plan.
• Develop, optimize, and launch medical device products and their manufacturing processes.
• Identify direct-material savings opportunities, assess feasibility, and validate projected financial benefits.
• Lead multidisciplinary Workshop, Kaizen, and VAVE events and coordinate site and external stakeholders.
• Plan project schedules, costs, resources, workforce loading, and CAPEX/OPEX activities.
• Develop and complete process validations, including IQ, SV, DOE, OQ, PQ, and TMV, before implementation.

Requirements

• Degree in mechanical, mechatronic, electrical, electromechanical, systems engineering, or a similar discipline.
• Minimum five years of experience in related positions.
• Experience with problem solving, project management, project leadership, lean practices, Six Sigma, and line transfers.
• Experience in ISO- and FDA-supervised environments and Good Manufacturing Practices.
• Experience writing and executing process validations, including IQ, SV, DOE, OQ, and PQ.
• Proficient oral and written English required.

Culture & Benefits

• Work focused on improving healthcare delivery and medical product manufacturing.
• Collaborative environment involving Manufacturing, Procurement, Planning, Quality, R&D, Marketing, and other functions.
• Emphasis on ownership, accountability, critical thinking, and continuous improvement.
• Equal employment opportunity and reasonable accommodation support.