DFM Sr Process Engineer

Align Technology; Ciudad Juárez; Presencial; MXN 1.296.536 - 1.666.975; Jornada completa

Descripción de la vacante

A leading medical device manufacturer is looking for a DFM Sr Process Engineer to optimize manufacturing processes and integrate new technologies. The ideal candidate will have a strong engineering background, 5+ years of experience in manufacturing process design, and knowledge of FDA regulations. Responsibilities include leading corporate teams and conducting experiments. The position offers a full-time employment opportunity in Ciudad Juárez, Mexico.

Formación

• Minimum of 5 years of experience in a similar position.
• Experience in the medical or pharmaceutical industry regulated by the FDA.
• Knowledge in ISO 13485:2003.

Responsabilidades

• Leads global corporate teams in various engineering areas.
• Designs experiments to evaluate changes in production.
• Establishes operational process limits using statistical methodologies.

Conocimientos

Mechatronics Engineering

Mechanical Engineering

Six Sigma certifications

Programming in C++

Statistical Analysis with Minitab

Educación

Completed professional degree in Engineering

Postgraduate studies in Manufacturing

Herramientas

Solidworks

ANSYS

MS Office Suite

Descripción del empleo

Overview

DFM Sr Process Engineer role at Align Technology.

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. This is achieved through the redesign or adaptation of existing infrastructure, as well as the design and implementation of 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.
• Directs, guides, and develops requirements for global corporate teams to ensure business goals are met.
• Conducts 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 experiments and test methods to evaluate the feasibility of a change point in the production environment.
• Designs 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.
• Establishes 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 consultancy and guidance on local Engineering projects to ensure proper risk assessment, integration, and interaction with the process.
• Use project management methodologies (Preferably AGILE/SCRUM) to:
• Determine scope
• Generate financial impact modeling
• Identify and break down the timeline of activities
• Ensure necessary resources
• Ensure compliance with activities

Skills, Knowledge & Expertise

• Completed professional degree in the following Engineering fields: Mechatronics Engineering, Mechanical Engineering, Electrical Engineering, Electronic Engineering, Computer Science Engineering, Science Engineering, Industrial Engineering
• Minimum of 5 years of experience in a similar position
• Postgraduate studies or specialization in Manufacturing, Design, Mechanical, Additive Manufacturing, Productivity, Quality Systems, Automation, Product Design
• Experience in the medical or pharmaceutical industry regulated by the FDA
• Previous work experience in roles related to Manufacturing Process Design, New Product Introduction to the Manufacturing Process, and Product Launch
• Experience in the Automotive industry
• Six Sigma certifications; Master Black Belt, Black Belt, Green Belt
• Knowledge in ISO 13485:2003
• 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
• Solidworks or equivalent
• MS Office Suite
• Expert level in MS Excel
• Innovative and system integrity-oriented thinking with attention to detail
• High level of critical and methodical reasoning aimed at problem-solving
• Outstanding skills in system failure analysis
• Outstanding skills in conceptualizing ideas and hypotheses involving the interaction of physical phenomena
• May supervise 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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Management and Manufacturing
• Industries
• Medical Equipment Manufacturing