Align

The Sr Automation Process Engineer is dedicated to addressing the most critical challenges in manufacturing design and production, leveraging expertise in critical disciplines (i.e. additive manufacturing, mechanical design, FMEA, etc.) to identify customer needs, validate solutions and scale manufacturing processes. 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.

This role focuses on accelerating the development of advanced applications and innovative technology solutions with internal teams. The engineer works to deliver tailored, high-impact solutions that reduce risks, improve ROI, and speed time-to-market for critical applications. By exploring, innovating, developing and validating, this position plays a key role in advancing the company’s competitive edge in the industry.

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 / Finance
• Local Manufacturing Teams
• Process Engineering / Manufacturing / Quality /Maintenance
• Leadership and management of multidisciplinary teams.
• Analytical thinking and focus on results.
• Effective communication with operational and management areas.
• Adaptability to change and orientation to continuous improvement.
• Process Optimization: Workflow analysis, waste reduction, line balancing.
• Continuous Improvement: Application of Lean, Six Sigma (DMAIC), 5S, SMED, VSM tools,8Ds.
• Project Management: Planning, execution and follow-up of process improvement and expansion projects.
• Quality Control: Development of control plans, FEA, SPC, internal audits.
• Technical Knowledge: Manufacturing processes, materials, basic automation, industrial ergonomics.
• 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.
• 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.
• 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:

o Determine scope

o Generate financial impact modeling

o Identify and break down the timeline of activities

o Ensure necessary resources

o Ensure compliance with activities

Skills, Knowledge & Expertise

• Completed professional degree in the following Engineering fields:

o Mechatronics Engineering

o Mechanical Engineering

o Electrical Engineering

o Electronic Engineering

o Computer Science Engineering

o Science Engineering

o 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
• Data Analysis: Use of tools such as Minitab, advanced Excel, Power BI, Python or SQL for statistical analysis and decision making.
• 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:

o ISO 13485:2003

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

• GD&T
• 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

About Align Technology

Your growth and well-being:

At Align, every smile matters. We’re committed to helping you thrive by supporting the health, growth, and well-being of our team members through a variety of tools and programs. While specific offerings may vary by location and role, Align employees can typically expect:

• Health and well-being programs to keep you thriving in both body and mind.
• Employee-exclusive discounts on Invisalign products.
• Learning opportunities through online learning resources and support for your individual development plans.
• Inclusive, global workplace that fosters collaboration, recognition and belonging.

Country and/or role specific details will be shared with you by your recruiter during the interview process.

Discover Align:

We are a global community of game-changers and smart team players, united by our belief in the power of a smile. Our dynamic team of exceptional employees is dedicated to transforming the industry and creating extraordinary outcomes every day.

Align’s core values of agility, customer, and accountability are more than words to work by, they are words we live by. The actions we take every day speak to who we are as a company and our focus on being truly impactful. We celebrate our differences, and the many ways we support one another— ultimately creating a more inclusive organization and world as we continue transforming smiles and changing lives.

We foster a culture where thinking differently and seeking new experiences are not just encouraged but celebrated. With the Align Mindset, we empower each other, ensuring every voice is heard and valued in an inclusive environment that inspires creativity and collaboration.

At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time.

As part of our commitment to innovation, Align Technology includes exocad and Cubicure, companies that enhance our offerings and extend our impact to industry transformation.

Eager to learn how we embrace our global differences and nurture employee well-being?

Explore Align's culture here!

Want to discover more about exocad and Cubicure? Click on their names for additional information.

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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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