Research and Development Project Manager

Company: RxSight, Inc.
Location: Aliso Viejo
Posted on: June 20, 2022

Job Description:

RxSight has commercialized the world's first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. This intraocular lens can be adjusted non-invasively while in the eye, allowing the post-cataract surgery patient to see clearly at distance without the use of eyeglasses or contact lenses. The application of light to the implanted Light Adjustable Lens (LAL---) will fine-tune the patient's lens power to their specific visual need. This technology sets the stage for a series of lens products from RxSight that will have widespread application in cataract and refractive surgery as well as outside the field of medicine.
OVERVIEW:Reporting to the Vice President of Engineering, the Manager LAL Projects will be responsible for facilitating and leading complex development and engineering projects focused on improving performance and quality of the RxSight Light Adjustable Lens (RxLAL) and its accessories. Responsibilities will include risk analysis and design control activities, performance of design processes including component and system design with tolerance analysis, assembly process development, qualification, and process documentation, validation, verification, engineering change requests, design history file creation and maintenance, and creation and maintenance of product specifications.
ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide continuous product development to support product improvement initiatives improving the performance and quality of RxSight Products.
• Plans and manages complex cross functional projects; directs and coordinates the activities. Projects may include external resources and contracted companies.
• Work closely with product development team to define and maintain RxSight' s product roadmap.
• Perform detailed analysis to ensure product performance, quality and manufacturability in addition to documenting the design and development.
• Owns risk management process for the RxLAL and its accessories.
• Leads and manages the development of engineering documents, validation protocols and reports.
• Maintains ownership of device specifications and risk management process for the RxLAL and its accessories
• Participates in drafting pertinent sections of Regulatory Filings as directed.
• Actively manage RxSight' s Design and Development process and associated procedures to ensure employee education and compliance.
• A proven track record in facilitating and leading complex cross-functional projects and proven success in achieving and maintaining high quality standards.
• Functional understanding of the full design cycle from concept to product release.
• Experience with medical device risk management process and ISO 14971 in developing and executing risk analysis for a regulated product.
• A consistent record of project management and leadership skills which inspire a strong, cohesive, team-focused work environment.
• The ability to establish priorities and build enthusiasm for projects.
• A proven "hands-on" leadership style within a fast-paced environment.
• Excellent communication skills in both oral and written formats, as well as excellent listening and problem-solving skills.
• The ability to interface effectively with all levels and functions within the organization.
  EDUCATION, EXPERIENCE, and TRAINING:
  • BS in Engineering or related discipline with a minimum of five years of experience and/or training; or equivalent combination of education and experience.
    COMPUTER SKILLS:
    • Project Management Software
    • Word Processing
    • -Spreadsheet Software

Keywords: RxSight, Inc., Aliso Viejo , Research and Development Project Manager, Executive , Aliso Viejo, California