Sr. Engineer, LAL Manufacturing

1 week ago

Aliso Viejo, United States RXSIGHT INC Full time
Job DescriptionJob DescriptionDescription:

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 Sr. Principal Engineer, IOL Development, the Sr. 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 manufacturing processes, materials, and equipment used to manufacture the LAL. Ensures successful transfer of these processes to the manufacturing line.


Lead the process manufacturing effort of state-of-the-art ophthalmic instruments.



ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Responsible for improving the performance and quality of RxSight products through technical development, focused primarily on the Light Adjustable Lens but also to special projects related to the next generation LALs and the Light Delivery Device.
  • Technical owner of key points of the manufacturing process of the Light Adjustable Lens. This includes an in-depth understanding, strong relationships with technicians, and the ability to see changes and improvements from conceptual phase through implementation.
  • Uses technical knowledge, insight and curiosity to design and execute experiments critical for project progression. Drives, monitors, and leads these experiments, including providing guidance to all involved personnel, including operators and technicians (hands-on).
  • Support the documentation of all aspects of the manufacturing process, including maintenance of accurate and organized records
  • Co-leads investigations or troubleshooting efforts pertaining to LAL manufacturing or development as-needed
  • Comfortable compiling, analyzing, and communicating results clearly to all relevant parties, along with partnering with other groups/departments to lead next steps.
  • Leads impactful discussions and meetings, including all necessary preparatory work to ensure efficiency
  • 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


Requirements:

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

  • Strong interpersonal skills – the ability to communicate effectively at multiple organizational levels
  • Clear communicator – understands how to distill data to have substantive discussions with the right audience
  • Engineering mindset – understands that while technical analysis and creativity are important, seeing things through with a hands-on approach is a must
  • Organizational skills – the ability to balance multiple projects
  • Continued willingness to learn – our process and our technology is unique


SUPERVISORY RESPONSIBILITIES:

  • None


EDUCATION, EXPERIENCE, and TRAINING:

  • Bachelor’s or Master’s degree in Engineering or Physics, or equivalent industry experience;
  • Strong preference for a minimum of 5 years in medical devices industry
  • Some experiences with practical mechanical designs
  • Experience with design and manufacturing to very tight tolerances preferred
  • Experience with thermoplastics preferred
  • 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


CERTIFICATES, LICENSES, REGISTRATIONS:

  • None


COMPUTER SKILLS:

  • Word Processing
  • Business Intelligence software (Power BI preferred)
  • Project Management System (SmartSheet preferred)
  • SolidWorks skill (preferred, not required)


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