Senior Manufacturing Engineer
Ciudad Juárez, Chihuahua, Mexico
TekniPlex Healthcare is seeking a Senior Manufacturing Engineer to lead strategic manufacturing initiatives focused on process development, continuous improvement, validation, automation, and operational excellence within a regulated medical device manufacturing environment.
This role will play a key part in optimizing manufacturing processes, supporting new product introductions, implementing advanced technologies, and leading cross-functional projects that drive productivity, quality, and business performance.
Required Qualifications
Education
• Bachelor's degree in Engineering or a related field.
• Advanced English with the ability to maintain technical and business conversations.
Experience
• Minimum of 5 years of Manufacturing Engineering experience.
• Medical device manufacturing experience preferred.
• Experience with process validation and regulatory requirements.
• Proven experience leading process improvement and operational excellence initiatives.
Technical Knowledge
• Lean Six Sigma Green Belt, Black Belt, PMP, CQE, or equivalent certifications.
• Lean Manufacturing, Six Sigma, Kaizen, Value Stream Mapping (VSM), 5S, and Poka-Yoke methodologies.
• SPC, DOE, PFMEA, CAPA, and statistical analysis tools.
• IQ, OQ, and PQ process validation activities.
• ERP systems and statistical software such as Minitab.
• FDA, ISO 13485, and GMP requirements.
• Line balancing, automation, and process optimization.
• CAD and facility layout management.
• Financial analysis and CAPEX project justification.
Key Responsibilities
• Lead manufacturing process development and continuous improvement initiatives.
• Implement Lean Manufacturing and Six Sigma projects to improve productivity and quality.
• Lead process and equipment validation activities (IQ/OQ/PQ).
• Support New Product Introduction (NPI) and process transfer activities.
• Develop and maintain SOPs, PFMEAs, control plans, and work instructions.
• Analyze manufacturing metrics and drive performance improvements.
• Lead CAPA investigations and root cause analysis activities using methodologies such as 8D, Ishikawa, and 5 Whys.
• Evaluate and implement new equipment, technologies, and automation solutions.
• Develop and maintain Value Stream Maps (VSM) and Manufacturing Operating Systems (MOS).
• Manage technical documentation, manufacturing routines, BOMs, and process-related records.
• Lead cross-functional engineering projects.
• Mentor and support the development of junior engineers and technicians.
• Ensure compliance with FDA, ISO 13485, GMP, and company quality standards.
Core Competencies
• Leadership.
• Lean Manufacturing Leadership.
• Problem-Solving Skills.
• Project Management.
• Effective Communication and Influence.
• Continuous Improvement Mindset.
• Automation and Innovation Focus.