Supports products from new product introduction through production, sustaining engineering, and end-of-life. Leads technical investigations, root cause analysis, engineering changes, validation, documentation, configuration and BOM management. Provides manufacturing troubleshooting, collaborates with quality, R&D, supply chain, suppliers, and contract manufacturers, and drives improvements in product quality, reliability, yield, cost, and efficiency. The role also supports compliance, risk assessments, first article inspection, and manufacturing readiness activities.
We are seeking a Product Engineer to support products throughout their lifecycle, from New Product Introduction (NPI) to mass production and sustaining activities. In this role, you will work closely with R&D, Manufacturing, Quality, Supply Chain, and Operations to ensure products are reliable, manufacturable, cost-effective, and compliant with quality standards.
Key Responsibilities
- Support products through NPI, production ramp-up, and sustaining engineering activities.
- Lead technical investigations, aid Jigs design for manufacturing, root cause analysis, and implementation of corrective actions.
- Drive Engineering Change Orders (ECOs/ECRs) and assess impact on manufacturing and supply chain.
- Provide engineering support to manufacturing and resolve complex technical issues.
- Manage product documentation, BOMs, and configurations in PLM/ERP systems.
- Lead validation and qualification activities related to product and process changes.
- Support suppliers and contract manufacturers to resolve technical challenges.
- Identify opportunities for cost reduction, yield improvement, and process optimization.
Skills, Knowledge & Expertise
- B.Sc. in Mechanical Engineering.
- 5+ years of experience in Product Engineering, Manufacturing Engineering, Sustaining Engineering, or NPI.
- Experience with SolidWorks, PDM, PLM and ERP systems.
- Experience in medical devices or other regulated industries.
- Strong analytical, problem-solving, and root cause investigation skills.
- Experience in managing engineering changes and product configurations.
- Excellent communication skills and ability to work in a global cross-functional environment.
- Fluent English (written and verbal).
Preferred Qualifications
- Knowledge of quality systems, risk management, and validation processes.
- Experience working with suppliers and contract manufacturers.
- Proven experience in operational excellence and lean manufacturing methodologies, including Kaizen, Gemba, root cause analysis and process optimization.
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.
Align Technology San Jose, California, USA Office
2820 Orchard Parkway, San Jose, CA, United States, 95134
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