Product Engineer

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 Product Engineer will provide deep technical support and serve as a key technical integrator for the RxSight Light Adjustable Lens (LAL) and its accessories. This role bridges R&D, Regulatory, Quality, Manufacturing, Supply Chain, and Commercial requirements to ensure product safety, performance, and manufacturability are fully supported by clear technical documentation and evidence.

The Product Engineer will take hands‑on ownership of technical documentation and execution activities—including product requirements, specifications, risk management files, verification protocols and reports, and design history file (DHF) updates. This role is directly responsible for generating, reviewing, and maintaining key records that support compliance and product performance. Core responsibilities include designing and executing feasibility and verification studies, owning change assessments including risk assessments, and translating design inputs into testable product specifications.

The Product Engineer will work closely with cross‑functional teams to plan and execute product testing, analyze results, and ensure that design and process changes maintain or enhance product quality and performance in an innovative, agile, fast‑paced environment.

• Contribute to the definition, refinement, and maintenance of product development requirements for LAL products and accessories.
• Translate user needs and design inputs into clear, testable requirements and acceptance criteria, in collaboration with R&D, Quality, Manufacturing, and Clinical as directed.
• Maintain and update product level technical documentation, including portions of device specifications, design history file elements, and risk management documents.
• Support development and documentation of testing strategies to demonstrate that product requirements are met.
• Lead study planning, protocol writing, study execution and coordination, data summarization and review, study reporting, and documentation of lessons learned, best practices, and next steps.
• Review and interpret product testing data (bench, optical, mechanical, chemical, biocompatibility, stability) to assess conformance to requirements and specifications, and summarize findings for cross functional teams.
• Collaborate with cross-functional team to ensure that R&D and verification builds, test units, and studies are aligned with product requirements and written protocols.
• Evaluate proposed changes from a holistic product perspective, assessing impact on optical and mechanical performance, safety, usability, manufacturability, supply continuity, cost, and regulatory implications.
• Develop and provide technical input into risk assessments for product changes, including identification of potential risks and implementation of mitigations.
• Draft or contribute to technical sections of change control packages, internal reports, and regulatory submission documents as directed, ensuring consistency with product requirements and risk assessments.
• Support continuous improvement of design & development documentation processes, product requirements, specifications, and verification approaches by incorporating previous lessons learned.
• Participate in cross functional projects as a product focused technical representative, presenting data and rationale clearly and concisely.

• Strong technical aptitude with the ability to understand and/or learn mechanical, materials, optical, and process aspects of the Light Adjustable Lens and its accessories.
• Experience working with product requirements, specifications, and verification/validation activities, preferably in a regulated environment.
• Ability…