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Senior Mechanical Engineer, LAL Engineering

3 months ago

Aliso Viejo, United States RxSight, Inc. Full time

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. manager, LAL Engineering, you will provide elegant solutions to streamline and expand the manufacture of the RxSight Light Adjustable Lens (LAL). You will work closely with their manufacturing and regulatory partners to ensure only the most practical and effective improvements to the manufacturing process may be implemented strategically and effectively. You will be a hands-on engineer and a strong communicator, able to quickly learn the process and rapidly generate creative solutions. You will be comfortable communicating and iterating these ideas collaboratively and, as a sole contributor, bringing these ideas to life in an expeditious manner with limited supervision. You will become a subject matter expert for the LAL Manufacturing Process. ESSENTIAL DUTIES AND RESPONSIBILITIES: Responsible for improving the performance and quality of RxSight products through technical development, focused primarily on the Light Adjustable Lens Subject matter expert for the LAL manufacturing line - capable of providing technical guidance to operators and peers, and lead investigations/improvement efforts. Coordinate with all relevant teams to ensure strong integration Establish project goals and requirements with cross-functional teams, ensuring cross-functional alignment with all parties at every stage of a project (no matter the size) Deliver elegant and creative solutions to increase manufacturing throughput and yield Comfortable compiling, analyzing, and communicating results clearly to all relevant parties, along with partnering with other groups/departments to lead next steps Design and prototype fixtures, tools, and equipment, utilizing CAD as needed. Strong understanding of DFM, GD&T, and machining/molding principles Develop processes to facilitate and optimize workflows for LAL technicians. Creatively reimagines processes, and develops plans to follow through Holistically observe and monitor the manufacturing process to understand bottlenecks and inefficiencies; provide continuous improvement based on these observations Strong sense of accountability - understands timelines and strives to meet them 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 GDPRequired Knowledge, SKILLS, and Abilities: The ability to conduct training and submit engineering change requests A hands-on approach to problem-solving, with the ability to close out tasks expeditiously Knowledgeable of SolidWorks PDM software Ability to communicate effectively both oral and written formats Effective problem-solving skills with the ability to apply solutions to multiple challenges Design control; verification and validation, design transferSUPERVISORY RESPONSIBILITIES: NoneEDUCATION, EXPERIENCE, and TRAINING: Bachelor's degree in Engineering with a minimum of 5 years of experience in medical devices, or equivalent combination of education and experience Effective analytical and problem-solving skills with the ability to apply creative solutions to challenges 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 basisCERTIFICATES, LICENSES, REGISTRATIONS: NoneCOMPUTER SKILLS: Word Processing Spreadsheet Software SolidWorks PDMSALARY RANGE: $110,000 To $125,000 Per Year