DFM Sr Process Engineer

Align Technology, Inc.; Chihuahua; Híbrido; MXN 600.000 - 1.200.000; Jornada completa

Descripción de la vacante

Align Technology, Inc. in Juarez, Mexico, is seeking a DFM Sr Process Engineer to optimize manufacturing processes and implement new infrastructure within the Design for Manufacturing group. The role aims to meet business goals through redesigns and the deployment of new capabilities.

You will collaborate with Global Corporate Teams, R&D, product design, and local manufacturing to drive risk assessment, experiments, and scalable, compliant processes across production.

Formación

• 5+ years of experience in a similar position.
• Experience in the medical or pharmaceutical industry regulated by FDA.
• Knowledge of ISO 13485 and medical device regulations.
• AGILE/SCRUM project methodologies.

Responsabilidades

• Leads and/or supports global corporate teams and local manufacturing teams.
• Evaluates risks, quantifies impact, and sets expectations for projects.
• Performs root cause analysis and designs experiments for process changes.
• Develops scalable manufacturing processes focusing on productivity and quality.

Descripción del empleo

DFM Sr Process Engineer

Department: Research & Development

Employment Type: Full Time

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 the following areas:
  • 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
• Intermediate - Advanced English