What are the responsibilities and job description for the Process Development & Engineering Manager position at RXSIGHT INC?
Job Description
Job Description
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 :
SUPERVISORY RESPONSIBILITIES :
EDUCATION, EXPERIENCE, and TRAINING :
CERTIFICATES, LICENSES, REGISTRATIONS :
