Manufacturing Engineer

TekniPlex; Ciudad Juárez; Presencial; MXN 420.000 - 640.000; Jornada completa

Descripción de la vacante

TekniPlex Healthcare in Ciudad Juárez, Mexico, is seeking a Manufacturing Engineer to design, optimize, and improve production processes for greater efficiency, quality, and safety.

You will drive continuous improvement using Lean and Six Sigma, validate processes, and maintain compliance with FDA/ISO13485 requirements.

This role requires 3 years of experience in production and cost reduction, with a degree in Industrial or related engineering.

Formación

• Industrial, Biomedical, Process, Electromechanical, or Mechatronics engineering degree.
• Minimum 3 years of experience in production processes and continuous improvement.
• Experience in cost reduction and resource optimization.

Responsabilidades

• Ensure production line uptime and continuity by solving technical problems.
• Drive continuous improvement with Lean and Six Sigma, root-cause analysis, optimization, line balancing, and Kaizen.
• Manage design, documentation, and updating of work/process instructions, line balancing, and validation.
• Apply validation tools (IQ/OQ/PQ) and maintain FDA and ISO 13485 knowledge.
• Maintain effective customer communication and provide status updates on process changes.
• Use PFMEA, 8D, SPC, Poka-Yoke, SMED, control charts, VSM, Gantt, and CAD for plant systems and maintenance.
• Manage projects including NPI, lead continuous improvement initiatives, and perform cost analyses.
• Safety: uphold safe processes and equipment in collaboration with Maintenance and EHS.
• Quality: deliver processes that meet high quality standards.

Conocimientos

Lean Six Sigma

Root cause analysis

Line balancing

Process optimization

New technologies

Kaizen

CAD software

SPC

Educación

Industrial Engineering

Biomedical Engineering

Process Engineering

Electromechanical Engineering

Mechatronics

Herramientas

CAD software

PFMEA

Quality systems

Gantt charts

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.

Manufacturing Engineer

TekniPlex Healthcare is seeking a Manufacturing Engineer to design, optimize, and improve production processes to maximize manufacturing efficiency, quality, and safety, ensuring continuity of production line activities and reducing costs and waste through continuous improvement.

3. POSITION REQUIREMENTS (SKILLS)

3.1 EDUCATION

Industrial Engineering, Biomedical Engineering, Process Engineering, Electromechanical Engineering, Mechatronics, or related field.

3.2 EXPERIENCE

3 years of experience in production processes and continuous improvement applied to process and resource optimization, as well as cost reduction.

4. ACTIVITIES AND RESPONSIBILITIES

• 4.1 Ensure production line uptime and continuity by promptly solving technical problems to meet company objectives.
• 4.2 Drive continuous improvement by implementing Lean and Six Sigma methodologies, root-cause analysis, resource optimization, line balancing, cost optimization, implementation of new technologies, and small improvements that generate gradual changes in production areas (Kaizen).
• 4.3 Manage processes, including design, documentation, and updating of work/process instructions, line balancing, and process and product validation.
• 4.4 Apply technical tools, including process/equipment/product validation (Master Validation Plan, IQ, OQ, and PQ), and maintain knowledge of FDA and ISO 13485 requirements.
• 4.5 Maintain effective customer communication, participate in customer calls to provide status updates on process changes, and support validations through clear and accurate communication.
• 4.6 Apply engineering tools and documentation such as PFMEA, 8Ds, problem solving, Statistical Process Control (SPC), Poka-Yoke, SMED, control charts, histograms, Value Stream Mapping (VSM), Gantt charts, and CAD software knowledge for plant systems and controls maintenance.
• 4.7 Manage projects and participate in New Product Introduction (NPI), lead and participate in continuous improvement projects, identify effective and timely solutions, perform manufacturing cost analysis, and design tooling and fixtures.
• 4.8 Safety: maintain safe processes and equipment for employees in collaboration with Maintenance and the EHS department.
• 4.9 Quality: create processes with high quality standards and support employees in delivering products that exceed customer expectations.