Senior Mechanical Engineer, LAL Engineering

RxSight, Inc.

Aliso Viejo, CA

$110,000 to $125,000 Yearly
Full-Time

Job Description

Company Info

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 GDP

Required 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 transfer

SUPERVISORY RESPONSIBILITIES:

None

EDUCATION, 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 basis

CERTIFICATES, LICENSES, REGISTRATIONS: