Process Engineer

Department: Operations

Location: EMEA-Israel

Description

About this opportunity

Align's Sleeves and Automation team is looking for a talented Process Engineer.

Our Sleeves products are used with the iTero scanner to reduce the risk of cross contamination and damage to the scanner.

The Sleeves Process Engineer Oversees All Operations Aspects Of The Product End-to-End, From Concept And Design Phase To Mass Production And On-going Support Including The Following

• Act as OPS Project manager for all New Products Introduction, cross functional coordination to achieve a robust design and production, following Align PLCM.
• Responsible for establishing Product/Production file, Product documentation, BOM, jigs/tools/Fixtures design
• Operation support for R&D during design and V&V stages
• Manage TK vendors and Critical vendors
• Responsible for shifting from prototype to mass production
• Responsible of full design transfer process during the PLC stages
  
  

In this role, you will…

• Responsible for leading the transfer of a new product from development to production. Leading and implementing NPI processes for a multidisciplinary product
• Constructing and maintaining detailed projects plan
• Set the right production strategy, setting the production to support the growing business and market's demand
• Leading Engineering changes as the prime interface to introduce necessary engineering/R&D changes while understanding the implications on Logistic, Testing and Production
• Create Product Portfolios and write Testing requirements
• Write test protocols and reports, Mold Validation protocols and reports, Process Validation protocols and reports. IQ/OQ/PQ Protocols and reports.
• Leading FAI process to all new products and responsible for the supplier quality
• Involved from design phase to assure DFX's (Assembly process, Manufacturability, design to cost etc).
• Define all documentations required to manufacture the product correctly and consistently (Test procedure, Assembly instruction etc.)
• Define and design jigs, tools, and fixture to allow repetitive and robust manufacturing with mass production orientation
• Work closely with production sites abroad – implementing processes and production tools
• Support production and implement solutions for production failures
• Construct and maintain complex Bills of Materials (BOM)
• Perform Training and accompany Prototype and NPI assembly
  
  

In this role, you’ll need …

• BSc degree in Mechanical Engineering or equivalent
• Minimum 5 years of proven experience in engineering environment
• Experience working with a PLM and CAD system such as SolidWorks
• Experience with mechanical assembly production line design - advantage
• Fundamental optics knowledge (polarization, lenses, mirrors, prisms…) – advantage
• Experience with medical device – advantage
• Skilled in Hebrew and English, speaking and writing
  
  

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Global Diversity Statement

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.

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.