DFM Process Engineer

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.

Leads and/or is part of and/or provides support to:
· Global Corporate Teams
o Research and Development
o Product Design
o Biomechanical Design
o Mechanical Design
o Software Development
o Materials Development
o Automation and development of new manufacturing technologies
o Marketing
o Finance
· Local Manufacturing Teams
o Process Engineering
o Manufacturing
o Quality
o 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:
o Establishing and monitoring "Key Performance Indicators (KPIs)" during the early stages of implementing a change point.
o Providing support and making design adjustments during the early stages of implementing change points.
o Providing support for conducting investigations and root cause analysis of internal problems and/or customer complaints reported in the field.
o 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:
o Determine scope
o Identify and break down activity timelines
o Ensure activity compliance

· Completed professional degree in the following Engineering fields:
o Mechatronics Engineering
o Mechanical Engineering
o Electrical Engineering
o Electronics Engineering
o Computer Science Engineering
o Science Engineering
o 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:
o ISO 13485
o JPAL (Japan Ministry of Health, Labor, and Welfare - Ordinance No. 169, 2004)
o SOR/98-282 (Canadian Medical Device Regulation)
o MDD 93/42/EEC (European Council Directive)
o 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
· 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

Intermediate English