R&D Cleanroom Technician II

Socket.dev; Aliso Viejo (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

RxSight seeks an R&D Cleanroom Technician II to support development and production in a controlled cleanroom environment in Aliso Viejo, CA. You will work with project owners, engineering, and manufacturing to resolve issues and evaluate materials and processes.

The role emphasizes precise manufacturing, rigorous testing, data logging, and proactive problem solving, with mentorship of junior staff and adherence to safety and regulatory requirements.

Qualifications

• High school diploma required.
• Minimum 3 years of experience in the medical device industry.
• Training per the position's training plan as documented in the control system.
• 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 completed within 30 days of hiring and yearly thereafter.

Responsibilities

• Manufacture prototype, pilot, and validation units with precision and quality control.
• Conduct rigorous testing on manufactured units and document results.
• Log data from manufacturing and testing processes for traceability.
• Monitor processes and report abnormalities promptly to relevant teams.
• Collaborate with engineering and manufacturing for materials and process evaluations.
• Operate and troubleshoot cleanroom equipment and maintain SOP compliance.
• Maintain clean and orderly work area, ensuring safety regulations are followed.
• Maintain thorough batch records including materials and deviations.
• Train and mentor junior technicians on cleanroom protocols and processes.
• Identify and implement improvements to enhance efficiency, productivity and quality.
• Lead team tasks and projects to achieve goals while staying compliant.

Skills

Cleanroom experience

Attention to detail

Leadership

Documentation

Problem solving

Math skills

Microsoft Office

Education

High school diploma

Tools

Smartsheet

Microsoft Excel

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:

The R&D Cleanroom Technician II will be responsible for supporting the development and production of advanced technology within a controlled cleanroom environment. After thorough training on the company's manufacturing procedures, the technician will independently execute process steps while proactively identifying and reporting any abnormalities in the manufacturing or R&D processes. This role also involves collaborating with project owners, engineering teams, and manufacturing departments to promptly address issues and contribute to materials and process evaluations.

Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Manufacture prototype, pilot, and validation units independently, ensuring precision and adherence to design specifications and quality standards.
• Conduct rigorous testing on all manufactured units, documenting results and addressing deviations from quality standards to ensure product integrity.
• Accurately log data from all manufacturing and testing processes. Comfortable compiling data for review by senior technicians, engineers and supervisors
• Continuously monitor the manufacturing and R&D processes, proactively identifying abnormalities or deviations. Report issues promptly and collaborate with project owners and relevant departments to address them.
• Work closely with engineering for R&D tasks and collaborate with manufacturing teams for materials and process evaluations, ensuring alignment and efficiency.
• Operate and monitor cleanroom equipment, ensuring optimal performance through regular checks. Perform basic troubleshooting to resolve equipment issues as they arise.
• Maintain a clean and orderly workspace, strictly adhering to SOPs and safety regulations. Ensure compliance with enhanced cleanroom protocols.
• Maintain thorough batch records, documenting materials, process parameters, and any deviations to ensure traceability and compliance.
• Train and mentor junior technicians, providing guidance on cleanroom protocols, equipment operation, and manufacturing processes.
• Participate in initiatives aimed at improving cleanroom efficiency, productivity, and quality. Provide input to enhance processes and address inefficiencies.
• Take a leadership role in team tasks and projects. Foster a collaborative environment to achieve project goals.
• Ensure all activities comply with safety standards and regulatory requirements. Stay updated on any regulatory changes and implement them accordingly.
• Troubleshooting and Problem-Solving (Addressing and resolving more complex issues that arise during manufacturing and testing, providing solutions and improvements).
• Stay adaptable in managing multiple tasks within the dynamic R&D cleanroom environment.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

• Proven experience in a cleanroom or controlled manufacturing environment.
• Strong understanding of cleanroom protocols and safety regulations.
• Experience working with engineering and manufacturing teams collaboratively on R&D and process evaluations.
• Experience working with small parts under the microscope
• Proficiency in operating and troubleshooting cleanroom equipment.
• Strong attention to detail and ability to maintain accurate documentation.
• Leadership skills and experience mentoring or training others.
• Excellent problem-solving abilities and a proactive approach to process improvements.
• Proficiency in recording data
• Basic math skills

EDUCATION, EXPERIENCE, and TRAINING:

• Education: High school diploma.
• Minimum 3 years of experience in the medical device industry.
• 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

COMPUTER SKILLS:

• Good understanding of Microsoft office programs such as work and Excel.
• Familiarity with Smartsheet is a plus.