The Role
Lead design-for-manufacturing efforts to optimize and scale production processes for medical devices. Conduct root-cause analysis, design experiments, validate changes to ISO 13485, integrate advanced manufacturing technologies, set KPIs, and support global and local teams through implementation and product launches.
Summary Generated by Built In
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
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
· 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
Skills, Knowledge & Expertise
· 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
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
Specific language requirements
Intermediate English
About
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.
Skills Required
- Completed degree in Mechatronics, Mechanical, Electrical, Electronics, Computer Science, Science, or Industrial Engineering
- Minimum 4 years of experience in a similar position
- Experience in the medical industry or pharmaceutical products regulated by the FDA
- Previous experience in manufacturing process design, new product introduction, and product launch
- Experience in the automotive industry
- Six Sigma certification (Master Black Belt, Black Belt, Green Belt)
- Knowledge of ISO 13485, JPAL, SOR/98-282, MDD 93/42/EEC, U.S. Code of Federal Regulations
- Finite element analysis experience (ANSYS, Abaqus, COMSOL, Matlab)
- GD&T (Geometric Dimensioning and Tolerancing) knowledge
- Programming in object-oriented languages such as C++, Python, or C#
- Experience with SQL, Big Data, Machine Learning, and AI
- Statistical analysis experience with Minitab
- Experience with SolidWorks or equivalent CAD software
- Proficiency with MS Office Suite and expert-level MS Excel
- Experience evaluating/implementing advanced 3D printing, CNC, and automation technologies
- Strong skills in root cause and system failure analysis, critical reasoning, and problem solving
- Ability to supervise, coordinate, and direct others
- Intermediate English language proficiency
Align Technology Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Align Technology and has not been reviewed or approved by Align Technology.
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Healthcare Strength — Health coverage includes medical, dental, vision, life, and both short‑ and long‑term disability, along with AD&D and wellness resources. Select locations add region‑specific programs such as medical coverage and Multisport, reinforcing breadth.
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Strong & Reliable Incentives — A corporate bonus plan outlines performance‑based rewards and eligibility, and compensation is described as competitive in commercial roles. Incentive structures in sales are portrayed as offering strong on‑target earnings potential.
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Retirement Support — Retirement programs feature a 401(k) plan with company contribution mechanisms, profit sharing, and a defined contribution pension plan. These elements emphasize long‑term financial security alongside salary and bonus.
Align Technology Insights
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The Company
What We Do
Twenty years ago, we pioneered the world's first clear aligners. Since then, we have continuously innovated with new products and technologies that are revolutionizing treatments for doctors and their patients. Invisalign clear aligners and the iTero Intraoral scanner help dental professionals achieve the clinical results they expect and deliver effective, advanced dental options to their patients. Helping change millions of lives, one smile at a time. Discover your straight path to a bright future at Align. As a part of our smart, diverse and fast-moving global team, you'll make an impact for the market leader that's moving an industry forward. Want to find out what’s next for us—and for you?
