Project Engineer, Quality Engineering

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.

Reporting to the Director of Product Strategy and Program Management, the Project Engineer will be responsible for planning, coordinating, and executing cross‑functional development and engineering activities that support projects focused on improving the performance, quality, and manufacturability of the RxSight Light Adjustable Lens (LAL) and its accessories. This role is the primary owner of cross‑functional plans and project execution across the product lifecycle.

The role will serve as a key partner to R&D, Manufacturing Operations, and Commercial Operations throughout the product lifecycle, with particular emphasis on feasibility, development, verification, and manufacturing transfer of new and modified products, processes, and materials.

Full‑time

• Partner with R&D to plan and execute development and verification activities for LAL products and processes, including feasibility studies, verification builds, and characterization testing.
• Serve as a key partner during development, verification, and manufacturing transfer, coordinating feasibility evaluations, pilot and production builds, equipment qualifications, and process validations. Studies may include process verification, biological evaluation, chemical characterization, and other safety and performance studies to verify product quality and performance.
• Coordinate weekly scheduling of shared R&D processing and testing equipment to support engineering studies and verification builds; negotiate and prioritize equipment, materials, and personnel utilization across teams to meet timelines.
• Help ensure teams stay on task and on time across all project phases, including requirements collection, project scoping and change descriptions, project planning, execution of studies, management of project deliverables, and project closure.
• Support evaluation and risk assessment of proposed changes including assessing technical need and strategic fit.
• Collaborate with cross functional teams to develop integrated project plans, maintain and track project timelines, monitor progress, and identify issues, risks, and mitigation actions.
• Collect and interpret test results and other technical data, summarize findings, and provide recommendations for next steps.
• Develop and maintain a structured repository of test results and technical data, ensuring traceability of test articles and results, facilitating data‑driven decision‑making and enabling efficient retrieval of historical testing results.
• Draft and drive technical documentation through the quality system, including protocols, reports, change control documentation, and contributions to the risk management file and design history file.
• Provide concise and accurate status updates to teammates and stakeholders, highlighting accomplishments, upcoming activities, risks, and key decisions.
• Support preparation of timelines, resource estimates, and budgeting inputs as directed.
• Ensure work is performed in compliance with applicable quality and regulatory requirements, including ISO 13485 and relevant ISO and FDA standards.
• Participate in and facilitate cross functional technical meetings, project reviews, standups, and design reviews, documenting decisions and action items and driving closure.
• Contribute to continuous improvement of project execution and documentation processes by regularly collecting team feedback, identifying gaps, proposing enhancements, and implementing continuous improvements.

• Ability to coordinate cross functional technical projects, build practical project plans, and help ensure on time completion of deliverables.
• Strong organizational skills, with the ability to manage multiple concurrent…