Description

The Design for Manufacturing department at Align Technology is responsible for optimizing existing processes and products, as well as integrating new ones into the General Manufacturing environment by redesigning or adapting existing infrastructure, as well as designing and implementing new infrastructure to meet business goals.

Department

Research & Development

Location

MEX-Juarez-Plant #2 P

Description

The Design for Manufacturing department at Align Technology is responsible for optimizing existing processes and products, as well as integrating new ones into the Global Manufacturing environment by redesigning or adapting existing infrastructure, as well as designing and implementing new infrastructure to meet business goals.

Key Responsibilities

Leads and/or is part of and/or provides support to:

Global Corporate Teams

Research and Development

Product Design

Biomechanical Design

Mechanical Design

Software Development

Materials Development

Automation and development of new manufacturing technologies

Marketing

Finance

Local Manufacturing Teams

Process Engineering

Manufacturing

Quality

Maintenance

Evaluates risks, quantifies/estimates impact, and sets expectations for global corporate teams.

Has the ability to manage engineering resources to define, monitor, and complete activities according to the needs of the organization or project.

Conducts/participates in root cause analysis through observation and analysis of physical and chemical phenomena intrinsic to the process to theorize, test, and quantitatively measure their effects.

Designs/participates in experiments and test methods to evaluate the feasibility of a change point in the production environment.

Designs/participates in the generation of scalable processes focused on productivity and quality, minimizing dependence on manual processes prone to failure.





Effectively and quantitatively communicates and provides feedback on any development element intended to be incorporated into the production environment.

Evaluates advanced 3D printing technology, CNC, as well as complex hardware and software subsystems integrated into the raw material transformation process.

Defines and/or participates in establishing operational ranges and process limits using statistical control methodologies to ensure process stability and scalability, as well as product conformity within established ranges.

Validates and documents change points in compliance with ISO 13485 prior to their implementation in the production environment.

Interacts with local manufacturing teams:

Establishing and monitoring "Key Performance Indicators (KPIs)" during the early stages of implementing a change point.

Providing support and making design adjustments during the early stages of implementing change points.

Providing support for conducting investigations and root cause analysis of internal problems and/or customer complaints reported in the field.

Providing consulting and guidance on local engineering projects to ensure proper risk assessment, integration, and interaction with the process.

Uses project management methodologies (Preferred; AGILE/SCRUM) to:

Determine scope

Identify and break down activity timelines

Ensure activity compliance

Skills, Knowledge & Expertise

Completed professional degree in the following Engineering fields:

Mechatronics Engineering

Mechanical Engineering

Electrical Engineering

Electronics Engineering

Computer Science Engineering

Science Engineering

Industrial Engineering

Minimum 4 years of experience in a similar position





Experience in the medical industry or pharmaceutical products regulated by the FDA

Previous work experience in roles related to manufacturing process design, introduction of new products to the manufacturing process, and product launch

Experience in the automotive industry

Six Sigma certifications; Master Black Belt, Black Belt, Green Belt

Knowledge in the following areas:

ISO 13485

JPAL (Japan Ministry of Health, Labor, and Welfare - Ordinance No. 169, 2004)

SOR/98-282 (Canadian Medical Device Regulation)

MDD 93/42/EEC (European Council Directive)

U.S. Code of Federal Regulations

Finite element analysis such as ANSYS, Abaqus, COMSOL, Matlab

GD&T;

Programming in an object-oriented language such as C++, Python, C#

SQL, Big Data, Machine Learning, AI

Statistical analysis with Minitab

Solid Works or equivalent

MS Office Suite

Expert level in MS Excel

Innovation-oriented thinking and system integrity with attention to detail

High level of critical and methodical reasoning aimed at problem-solving

Outstanding skills for system failure analysis

Outstanding skills for conceptualizing ideas and hypotheses involving the interaction of physical phenomena

Ability to supervise, coordinate, and/or direct others

Specific Language Requirements

Intermediate English

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Equal Opportunity Statement

Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category.

Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.

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📌 DFM Process Engineer (Ciudad Juárez)
🏢 Align Technology
📍 Ciudad Juárez