Design Quality Engineer

Description

About this opportunity
Design Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for the Company. This is a key technical position, affecting part quality for both installed base and NPI products.

Key Responsibilities

In this role, you will…
Daily duties include supporting the project team (R&D, SQA, Product, System and so on) during the development of a project. Our engineers review each design input and output deliverable throughout the development process and resolve compliance impediments as they arise. As a senior engineer the candidate will be responsible for defining two major evolving components in our work:
Implementing AI in our processes – What are the regulatory requirements for implementing AI in a medical device and how to implement it in our development lifecycle.
Cybersecurity work instructions in compliance with the new FDA guidance, train the various teams on the guidance and its implications to our process, and establish best practices for supporting post market vigilance.

Skills, Knowledge & Expertise

In this role, you’ll need …
Bachelor's Degree in an engineering or equivalent
At least 4-6 years of experience in quality engineering in the medical device industry- Must
Fundamental knowledge of ISO13485:2016 and FDA requirements (e.g. CFR Part 820) EU Medical Device Directive & new MDR, ISO 14971, IEC 62366 and ISO 62304 standards for the medical devices industry
DHF compilation, including Design Controls process and other applicable regulatory, QA and GMP aspects.
Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management and how they are applied in the product development lifecycle.
Good ability to comprehend multi-disciplinary systems and processes
Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).
Ability to work independently with minimal supervision
Computer skills (Microsoft Word, Excel, PowerPoint)
Working knowledge in Statistical Tools, e.g. miniTab (Measurement Systems Analysis, Process Capability and Statistical Process Control)
Knowledge of various quality system methodologies Lean, 5 Why’s, DFMEA, PFEMA, PPAP, etc. preferred
Strong written and verbal communication skills
Strong organizational skills
Excellent written and spoken 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.