Process Development & Engineering Manager

Job Type

Full-time

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.

Overview

Reporting to the VP of LAL Chemistry, the Manager of Process Development and Engineering will be responsible for leading and managing activities related to the selection, qualification, and integration of core LAL IOL materials into production. This includes overseeing the development and optimization of manufacturing processes, ensuring successful implementation of qualified materials in scaled production, and addressing troubleshooting needs to maintain target yields.

Additionally, the Process Development and Engineering Manager will oversee the development and implementation of predictive analytics tools to enhance process optimization and expedite troubleshooting efforts in LAL IOL manufacturing process.

In this role, the candidate is expected to work in a highly collaborative, cross-functional, and fast-paced environment interacting frequently with the Manufacturing, Quality and Regulatory Affairs groups.

Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Lead the selection and qualification processes for core LAL IOL materials to ensure supply chain continuity.
• Oversee the transfer of qualified materials from development to production.
• Collaborate with the strategic procurement team to establish and maintain supply chain redundancy for key LAL IOL materials.
• Develop and optimize manufacturing processes for new LAL IOL prototypes.
• Manage the process transfer of new LAL IOL prototypes from pilot scale to full-scale production.
• Partner with the R&D Chemistry, Materials Processing, and Data Analytics teams to build and maintain a comprehensive materials database.
• Act as a subject matter expert to guide the data analytics team in developing predictive models for optimizing LAL IOL composition and processing based on historical materials characterization and production data.
• Author clear and concise protocols, engineering documents, and validation reports.
• Lead and mentor a team of junior chemists and engineers by setting key performance indicators (KPIs) and execution plans to achieve development and manufacturing objectives.
• Contribute to regulatory strategy development and support regulatory submission activities.
• Assist in equipment maintenance and lead efforts for equipment upgrades to meet operational needs.
  
  

Required Knowledge, Skills And Abilities

• Strong background in materials science, chemical engineering, or process engineering with a focus on soft materials.
• Extensive experience in process development, optimization, and scale-up.
• In-depth knowledge of polymeric materials characterization techniques, including chromatography, spectroscopy, optical analysis, and thermal analysis.
• Proficient in data analytics for both small molecules and macromolecules.
• Familiarity with database development and functionality to support materials and process data management.
• Basic understanding of molecular simulation tools and polymer analytics.
• Creative technical skills for developing innovative solutions in the process and product development lifecycle.
  
  

Supervisory Responsibilities

• Manage and lead a team of chemists and chemical engineers, ensuring effective collaboration and high performance.
• Monitor and evaluate staffing needs, organize workloads, and assign tasks to align with project and organizational priorities.
• Clearly communicate organizational objectives, ensuring team alignment and understanding of goals and timelines.
• Provide regular performance feedback, develop employee growth strategies, and foster professional development.
  
  

EDUCATION, EXPERIENCE, And TRAINING

• Ph.D. or Master’s degree in Materials Science, Chemical Engineering or process Engineering with emphasis on soft materials).
• 5-10 years of relevant work experience and/or training; or equivalent combination of education and experience.
• Strong preference for a minimum of 2 years in medical devices industry where polymer chemistry is a critical element essential in the product.
• Familiarity with ISO standards, specifically: ISO 11979 and ISO 10993.
• Excellent verbal and writing skills are required.
• 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
  
  

Certificates, Licenses, Registrations

• None
  
  

Computer Skills

• MS Office
• Spreadsheet Software
• Laboratory Information Management System
  
  

Salary Description

$120,000 - $160,000