R&D Cleanroom Technician II

RxSight, Inc.; Aliso Viejo (CA); Hybrid; USD 60.000 - 85.000; Vollzeit

Zusammenfassung

RxSight, Inc. in Aliso Viejo, California, seeks an R&D Cleanroom Technician II to support development and production in a controlled environment.

You will train on procedures and independently execute process steps while collaborating with engineering and manufacturing teams to address issues, ensuring traceability of materials and processes through thorough documentation. This role emphasizes rigorous testing, SOP adherence, leadership in team tasks, and continuous improvement of cleanroom

Qualifikationen

• High school diploma required.
• Minimum 3 years of experience in the medical device industry.
• Training to be completed per the training plan within 30 days from hire and annually.
• Experience in cleanrooms and controlled manufacturing environments.
• Strong documentation and data logging skills.

Aufgaben

• Manufacture prototype, pilot, and validation units to specification.
• Test units and address deviations to maintain quality.
• Log data from manufacturing and testing for traceability.
• Monitor processes and promptly report abnormalities or deviations.
• Collaborate with engineering and manufacturing on evaluations and improvements.
• Operate and troubleshoot cleanroom equipment and maintain SOP adherence.
• Mentor junior technicians on SOPs, safety, and manufacturing processes.
• Lead team tasks to achieve project goals and improve efficiency.

Kenntnisse

Cleanroom experience

Documentation

Leadership

Problem solving

Data recording

Attention to detail

Team mentoring

Regulatory compliance

Ausbildung

High school diploma

Tools

Microsoft Excel

Smartsheet

Microsoft Word

Jobbeschreibung

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.