Engineer, LAL Manufacturing
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Job Description
RxSight is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company s mission is to revolutionize the premium cataract surgery experience by allowing surgeons to partner with their patients to achieve optimized results for every unique eye.
OVERVIEW:
Reporting to the Associate Director, Mold Manufacturing & Engineering, the Engineer, LAL Manufacturing is responsible for improving the efficiency and quality of RxSight products focused primarily on the Light Adjustable Lens (LAL), an intraocular lens.
Acts primarily as a sole contributor, while also providing technical guidance to a multi-disciplinary R&D group responsible for the design and development of high-quality molds, materials, and equipment used to manufacture the LAL. Ensures successful transfer of these products and processes to the manufacturing line.
Lead the process manufacturing effort of state-of-the-art ophthalmic instruments.
Requirements:ESSENTIAL DUTIES AND ACCOUNTABILITIES:
- Responsible for improving the performance and quality of RxSight products through technical development, focused primarily on the Light Adjustable Lens but also special projects related to the Light Delivery Device.
- Co-leads investigations or troubleshooting efforts pertaining to the relationship between molding technique, mold manufacturing, and curable formulations.
- Performs in-depth analyses of the compression mold manufacturing process, revealing gaps and areas for improvement and optimization. Partners with the mold manufacturing team and leads the effort to transfer these improved processes to manufacturing.
- Develops expertise in high-precision optical metrology comfortable collecting, organizing, analyzing, and presenting data expeditiously
- Subject matter expert for much of the mold manufacturing line able to provide technical guidance to operators and machinists, and lead investigations/improvement efforts. Coordinate with all relevant teams to ensure strong integration.
- Collaborates with mold manufacturing and engineering to formulate and execute robust and detailed designs-of-experiments.
- Support the documentation of all aspects of the mold manufacturing process alongside maintenance of accurate and organized records.
- Understand engineering drawings (basic familiarity with navigating within SolidWorks), ensuring accurate representations of mold designs and modifications.
- Demonstrate a hands-on approach, actively participating in the mold and IOL manufacturing processes as needed.
- Comfortable compiling, analyzing, and communicating results clearly to all relevant parties, along with partnering with other groups/departments to lead the next steps. Data analysis may require analysis of variance, normal distribution calculations, and other statistical techniques.
- The ability to author and drive documents such as technical reports through RxSight s quality management system
- Self-motivated, proactive, and able to work effectively under minimal supervision.
- Familiarity with regulatory standards (ISO 11979, ISO 13485, ISO 14971) and regulatory strategies
- Familiarity with GMP and GDP
EDUCATION, EXPERIENCE, and TRAINING:
- Bachelor s degree in Engineering or Physics, or equivalent industry experience;
- Strong preference for a minimum of 3 years in medical devices industry
- Strong understanding of manufacturing methods and GD&T
- Strong understanding of metrology techniques and their respective limitations
- Training to be completed per the training plan for this position as maintained in the document control system.
- Training to be completed per the training plan for this position as maintained in the document control system
- The training requirements on TRN-10007 Insider Trading Policy, TRN-10008 Global Anti-Bribery and Anti-Corruption Policy, and TRN-10009 Code of Business Conducts and Ethics must be diligently completed within 30 days from the hiring date and on an annual basis
COMPUTER SKILLS:
- Word Processing
- Design Software (SolidWorks)
- Business Intelligence software (Power BI preferred)
- Data Analysis Software (Excel and/or Minitab)
- Project Management System (SmartSheet preferred)