Entry Level - Sustaining Engineer (Medical Technology)

Location: Tijuana, Baja California, Mexico; onsite

Company

hirify.global is a medical technology company developing clinically differentiated orthopedic solutions, integrated technologies, and products that support active lifestyles and improved patient outcomes.

What you will do

• Develop robust manufacturing processes, visual aids, work instructions, rework plans, and line-balancing solutions.
• Resolve manufacturing issues using 8D problem-solving, root cause analysis, scrap reduction, process capability improvement, and other engineering techniques.
• Support IQ/OQ/PQ validation protocols, initial production runs, product and process changes, product transfers, and insourcing activities.
• Design and evaluate assembly equipment, ergonomic workstations, fixtures, and tooling for assembly and subassembly operations.
• Track NCMRs and CAPAs, ensure assigned actions are completed accurately and on time, and participate in continuous improvement projects with OPEX.
• Maintain GMP documentation in compliance with ISO 13485, FDA requirements, applicable manufacturing regulations, SOPs, and operational standards; plan and monitor projects using WBS and other project management tools.

Requirements

• Bachelor’s degree in Industrial, Mechanical, Electronic Engineering, or a related field.
• At least 1 year of experience in a Manufacturing Engineering role within a maquiladora or manufacturing environment.
• Intermediate English proficiency, including technical reading and conversational skills.
• Knowledge of IQ/OQ/PQ validation protocols and ISO 13485 requirements.
• Familiarity with Engineering Core Tools, including MSA and SPC.
• Knowledge of Lean Manufacturing tools and methodologies, including Kaizen, Gemba, SMED, PDCA, DMAIC, Bottleneck Analysis, Root Cause Analysis, 5S, Poka-Yoke, and JIT.
• Knowledge of project management methodologies and tools, including WBS and CPM.
• Upload an English resume.

Culture & Benefits

• Equal employment opportunities are provided based on merit, experience, and work-related criteria.
• Reasonable accommodation is available for employee beliefs and practices when consistent with company policies and applicable law.
• The company values the unique contributions of its employees.