Senior Manufacturing Engineer

TekniPlex; Ciudad Juárez; Presencial; MXN 700.000 - 1.050.000; Jornada completa

Descripción de la vacante

TekniPlex Healthcare is seeking a Senior Manufacturing Engineer in Ciudad Juárez, Mexico, to lead strategic manufacturing initiatives in a regulated medical device environment. The role emphasizes process development, validation, automation, and cross-functional project leadership.

Ideal candidates bring 5+ years in manufacturing engineering, experience with process validation, and knowledge of FDA/ISO13485/GMP guidelines, enabling improvements in productivity, quality, and compliance.

Formación

• Bachelor's degree in Engineering or related field.
• 5+ years of Manufacturing Engineering experience.
• Medical device manufacturing experience preferred.
• Experience with process validation and regulatory requirements.

Responsabilidades

• 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.

Conocimientos

Lean Six Sigma

Process Validation

Regulatory Understanding

Project Leadership

English Proficiency

Analytical Thinking

Educación

Bachelor's degree in Engineering

Advanced English

Herramientas

Minitab

ERP systems

Descripción del empleo

Imagine: A Career with Purpose and Possibilities

Imagine being part of a global team of problem-solvers whose innovations in material science help improve lives. Every day, you transform ideas into impact by using science, technology, and creativity to address real-world challenges.

At TekniPlex, you will collaborate with more than 8,000 colleagues across 12 countries, all united by a common purpose: creating smarter and safer solutions that impact everyday life. Through TekniPlex Healthcare, we help develop critical solutions for the medical industry that improve safety and quality of life for millions of patients worldwide.

About TekniPlex Healthcare

TekniPlex Healthcare develops and manufactures critical components, medical devices, and packaging solutions for the healthcare and pharmaceutical industries. Our commitment to innovation, quality, and regulatory compliance enables us to serve as a trusted partner to some of the world's leading healthcare organizations.

Senior Manufacturing Engineer

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

• Effective Communication and Influence.