Product Engineer

RxSight, Inc.•Aliso Viejo, CA

About The Position

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 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.

Requirements

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 to critically analyze and interpret experimental and verification data, identify trends, and connect results to product specifications and product risk profile.
Strong technical writing skills, including experience drafting or contributing to protocols, reports, and/or other relevant technical documentation.
Details oriented with strong organizational skills and the ability to manage multiple initiatives concurrently.
Effective collaborator with cross-functional teams including R&D, Operations, Quality, and Regulatory, and able to discuss and explain technical issues at the appropriate depth for each audience.
Self motivated, curious, and eager to develop a deep understanding of the LAL technology, its product performance, and its clinical context over time.
Bachelor’s degree in engineering (ideally chemical, biomedical, or materials), chemistry, materials science, or related technical discipline.
Minimum of 3-4 years of experience within medical devices or other related life sciences field is preferred.
Working knowledge of medical device design controls, performance and process verification requirements, and risk management concepts (e.g., FMEAs, ISO 13485, ISO 14971).
Familiarity with good manufacturing practices (GMP) and good documentation practices (GDP). Experience with good laboratory practices (GLP) is a plus.
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
Proficiency with common productivity, communication, and presentation tools (e.g., Microsoft Word, PowerPoint, and Visio), and ability to learn company specific systems.
Proficiency with common data analysis tools (e.g. Excel; statistical tools a plus).

Nice To Haves

Experience with intraocular lens-specific standards (e.g., ISO 11979, ISO 10993) is a plus.
Project Management software is a plus (SmartSheet preferred).
Business Intelligence software is a plus (Power BI preferred).
Quality management system software is a plus.

Responsibilities

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.