Project 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 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. The Project Engineer will coordinate day to day execution of engineering builds, studies, and verification activities, including scheduling shared processing and testing equipment, ensuring teams stay on task and on time, driving completion of technical documentation such as protocols, reports, and risk management deliverables, and clearly documenting results and data. The successful candidate will combine strong technical aptitude with excellent organizational and communication skills, operating comfortably in a fast-paced, innovative, highly regulated medical device environment.

Requirements

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 studies, builds, and documentation packages while maintaining attention to detail.
Proficiency in analyzing test data, identifying trends, and connecting results to product performance, safety, and process capability and making informed recommendations.
Clear, concise written and verbal communication skills, including experience preparing technical protocols, reports, and summaries for varied audiences.
Ability to collaborate effectively with R&D, Operations, Quality, Regulatory, and Supply Chain, maintaining a respectful, constructive, solution oriented working style.
Self motivated, proactive, curious, and eagerness to learn and attain mastery of the medical device product lifecycle in a fast-growing, entrepreneurial, novel technology company. Strong desire to develop deep understanding of LAL technology, its performance characteristics, and its manufacturing processes.
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 preferred.
Working knowledge of medical device quality and regulatory frameworks is a plus, including familiarity with design controls and risk management, and familiarity with key ISO standards and FDA regulations relevant to medical device testing.
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 Excel, Word, PowerPoint, and Visio), and ability to learn company specific systems.

Nice To Haves

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

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.