Process Engineer II , Orthopedics

jj; Ciudad Juárez; Presencial; MXN 450.000 - 650.000; Jornada completa

Descripción de la vacante

Johnson & Johnson seeks a Process Engineer II Orthopedics in Juarez to advance orthopedic manufacturing projects. You will collaborate on engineering tasks, manage schedules, control budgets, and ensure compliance with medical device regulations. The role emphasizes lean methods, process validation, and CAPA/NCR handling.

You will work under guidance with cross-functional teams to deliver quality products that meet regulatory standards while improving safety and efficiency in the plant.

Formación

• B.S. Engineering or Science degree required.
• 2–4 years in manufacturing/design engineering.
• Six Sigma Green Certification and/or project management methodology preferred.
• Ability to read and understand engineering drawings and translate into process information.

Responsabilidades

• Collaborate in engineering projects to ensure on-time, on-budget delivery with quality and customer service.
• Maintain project plans and schedules, review designs, monitor progress and budget.
• Plan and schedule changes, coordinate activities, and resolve problems.
• Oversee technical aspects of projects via coordination meetings and communications.
• Prepare and present status reports; analyze data and trends to guide actions.
• Follow change control processes; conduct tests and validate processes.
• Prepare/c Review capital and expense forecasts and CARs.
• Maintain compliance with regulations and quality systems (QSR, ISO 13485, FDA controls).
• Manage NCR and CAPA processes for product non-conformances.
• Maintain safe, compliant working environment; ensure OSHA and machine guarding requirements.
• Support safety and industrial hygiene objectives; communicate issues to management.

Conocimientos

Accelerating

Communication

Detail-Oriented

Execution Focus

Lean Manufacturing

GMP

MSAT

Project Engineering

Problem Management

Project Management Tools

Report Writing

Safety-Oriented

Educación

B.S Engineering Degree or Science Discipline

Herramientas

ERP Systems

Descripción del empleo

Job Function

Supply Chain Engineering

Job Sub Function

Process Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Juarez, Chihuahua, Mexico

Job Description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

"Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.”

We are searching for the best talent for Process Engineer II Orthopedics to be in Juarez City

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Under general supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position responsibilities may include, but are not limited to:

• Collaborate in engineering projects ensuring that projects are completed on time and within budget with no impact to quality or customer service.
• Controls and maintains project plan and schedule by reviewing design, specifications and monitoring project progress, and project budget.
• Plans and schedules project changes; coordinating activities; recommending actions and resolving problems.
• Through project coordination meetings and other forms of communication, oversees and coordinates the technical aspects of the project.
• Approves and plans expenditures; and keeps an accurate record of all elements of the project
• Prepares and presents project status reports in formats adequate to different organizational levels by collecting, analyzing, and summarizing information and trends; recommending actions.
• Follows the Ethicon change control process for all applicable projects.
• Confirms product performance by designing and conducting tests and performs process validation on new, transferred or modified processes
• Prepares/reviews capital & expense forecasts for assigned projects.
• Prepares capital authorization requests (CAR).
• Maintains project integrity and reputation through compliance with state and federal regulations.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Ensures effective use of engineering and quality systems and adherence to quality system regulations (QSR). Ensures compliance to the quality policy in all activities.
• Manages the NCR and CAPA process by documenting, investigating, root cause analysis, and implementing corrective actions for product non-conformances.
• Maintains safe and clean working environment by enforcing procedures, rules, and regulations.
• Ensures all OSHA and J &J Machine Guarding requirements are met.
• Supports and promote the safety and industrial hygiene objective of the plant
• Responsible for communicating business related issues or opportunities to next management level
• Other responsibilities may be assigned and not all responsibilities listed may be required.

Qualifications / Requirements

• B.S Engineering Degree or Science Discipline
• Approximate experience, or equivalent knowledge and skills, necessary to satisfactorily perform the position responsibilities. 2 to 4 years’ experience in manufacturing/design engineering.
• Six Sigma Green Certification and/or other project management methodology is preferred.
• Able to read and understand engineering drawings and translate product drawings into process information
• Hands on experience with manual assembly equipment and/or processes
• Position requires excellent organizational and communication skills (written and oral, fluent in English)
• Ability to make and manage good relationships
• Presentation skills
• Analytical and problem-solving skills
• Initiative and results/target focused
• An understanding of Lean Manufacturing and lean principles with an ability to promote and drive continuous improvement
• Understanding of design and production costs to include waste, downtime, scrap and re-work
• Understanding of calibration concepts and Measurement systems.
• Experience with the essential requirements of the Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment in design control and process validation
• Experience on medical device (Class II or Class III) projects.
• Experience utilizing enterprise resource planning (ERP) tools.
• Understanding of customer expectations and deliverables with an awareness of the impact of failure/cost of poor quality

Required Skills:

Preferred Skills:

• Accelerating
• Communication
• Detail-Oriented
• Execution Focus
• Facility Management
• Good Manufacturing Practices (GMP)
• Lean Manufacturing Principles
• Lean Supply Chain Management
• Manufacturing Engineering
• Manufacturing Science and Technology (MSAT)
• Problem Management
• Project Engineering
• Project Management Tools
• Project Support
• Report Writing
• Safety-Oriented
• Science
• Technology
• Engineering
• and Math (STEM) Application
• Technologically Savvy