Align

Supports manufacturing floor activities and participates in improving existing processes and developing new technologies. Conducts technical investigations of complaints related to the product or manufacturing process. Executes internal and/or external contractor audits (Not applicable to Itero business). Participates in investigations of corrective actions related to customer complaints. Responsible for supporting production and the development of new technologies. Collaborates with R&D in the development of new processes. Participates in process, software, and equipment validations, with support from senior engineers when necessary. Conducts technical investigations of complaints related to the product or manufacturing process (Applies only to Itero business).

Key Responsibilities

• Implement and maintain process control and monitoring systems. Develop inspections and test methods. Conduct test method validations, Gauge R&Rs, depending on feasibility.
• Develop and implement statistical quality control methods and systems to reduce reliance on production inspection.
• Implement continuous improvement projects for processes and products.
• Define and implement cost reduction, scrap reduction, and operations optimization projects.
• Lead internal and cross-functional teams in process development and improvement projects.
• Validate processes, equipment, and software (IQ, OQ, PQ), with support from senior engineers if needed.
• Coordinate risk evaluations in the analysis of new processes and/or products.
• Coordinate meetings and lead corrective and preventive action (CAPA) projects.
• Document, define, measure, and improve current manufacturing processes using statistical quality control techniques and methodologies.
• Ensure that manufacturing processes, techniques, and tools are optimal in terms of quality and productivity.
• Research, develop, and implement new manufacturing processes, methods, and technologies in collaboration with senior process engineers or other resources.
• Integrate and automate manufacturing processes and systems when appropriate and when tangible benefits to operations are identified, with support from senior engineers if necessary.
• Implement and coordinate continuous improvement methodologies and techniques.
• Define process capabilities; monitor and audit/gemba processes; provide technical support to existing operations and new product projects.
• Develop and implement training courses for equipment and processes. Develop support materials as needed.
• Optimize equipment utilization. Determine and implement plant layout and material flow for operations optimization. Specify and implement material handling equipment that optimizes operations and minimizes costs.
• Follow the guidelines in the Internal Work Regulations regarding safety, relationships with other workers, and care of equipment, materials, facilities, and other company-owned resources.
• Monitor the effective achievement of objectives and deadlines assigned to the group.
• Comply with all safety policies, practices, and procedures. Report all hazardous activities to the supervisor and/or Human Resources.
• Participate in team dynamics and efforts to achieve company and departmental goals.
• Other tasks may be assigned.
• May supervise others.

Skills, Knowledge & Expertise

Desirable education, skills and/or experience

• Degree in Manufacturing, Mechanical, Electrical, Industrial Engineering, or related field
• 3–5 years of experience in mechanical or process engineering related to the medical industry
• Experience in Six Sigma projects
• Experience in manufacturing operations for medical devices, pharmaceuticals, and/or regulated environments (FDA)
• Preferably knowledgeable in the following areas:
• ISO 13485
• 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

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.

Applicant Privacy Policy:

Review our Applicant Privacy Policy for additional information.

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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