Senior Manufacturing Engineer (Medical Devices)

Location: Tijuana, Baja California, Mexico

Company

hirify.global develops healthcare products and technologies focused on improving patient outcomes and sustaining lives.

What you will do

• Lead the transfer and integration of manufacturing processes from other hirify.global facilities, including implementation, validation, and operational readiness.
• Drive continuous improvement initiatives to increase productivity, improve first-pass yield, reduce scrap, and strengthen manufacturing performance.
• Design and implement manufacturing tools, fixtures, inspection equipment, and process improvements for safe and efficient production.
• Analyze manufacturing data, investigate root causes, and implement sustainable corrective actions.
• Plan manufacturing capacity strategies covering equipment, labor, space utilization, and maintenance requirements.
• Collaborate with operations, quality, suppliers, and cross-functional stakeholders on technical challenges and engineering projects.

Requirements

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related discipline.
• 3–5+ years of experience in manufacturing engineering, process development, process transfer, or continuous improvement in a regulated manufacturing environment.
• Experience leading end-to-end manufacturing process validation, including IQ, OQ, and PQ methodologies.
• Ability to perform root cause analysis and implement corrective actions.
• Experience collaborating with operations, quality, suppliers, and technical stakeholders.
• Strong project management, organization, prioritization, communication, and technical leadership skills.

Nice to have

• Experience in medical devices, healthcare, life sciences, or other highly regulated manufacturing industries.
• Knowledge of FDA Quality System Regulations, 21 CFR Part 820, ISO 13485, CAPA, and quality system requirements.
• Experience with manufacturing transfers, new product introductions, or site expansion projects.
• Knowledge of Lean Manufacturing, Six Sigma, manufacturing documentation, process instructions, routings, and bills of materials.
• Ability to mentor technicians, engineers, or cross-functional team members.

Culture & Benefits

• Work in a healthcare-focused environment centered on improving patient outcomes.
• Collaborate across manufacturing, quality, supply chain, operations, and supplier teams.
• Contribute to a culture of ownership, trust, courage, and accountability.
• Support reasonable accommodations during the application and interview process.