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Medical Device Assembler
4 months ago
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 LAL Manufacturing Technician, reporting to the Manager LAL Manufacturing, will focus on fully understanding the company's technology. After training in manufacturing procedures, the employee needs to be capable of executing each process step meeting time and quality standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manufacturing Process:
This individual will interact with the other functions including but not limited to Engineering, Quality, Warehouse, Planning, Chemistry and R&D. It is expected that this individual will have the depth and breadth of experience to contribute to the overall manufacturing of the LAL lenses. The LAL Manufacturing Associate Technician must complete the work with the highest Quality standards possible within the allowed time given to maintain the highest efficiencies.
- Employees may be expected to execute any of the following activities based on training and skillset:
- Cleanroom Activities:
- Gowning/Kanban Inventory Replenishment
- Cleanroom Monitoring
- Cleaning of Molds & Lens Holders
- Cleaning of lens caps & cases
- Haptic Cutting, polishing, cleaning, inspection, and sorting
- Label Production & application
- Tyek Pouching of Lenses
- Silicone Lens Molding
- Conducting lens testing according to established work instructions utilizing a variety of equipment such as: dimensional, optical and mechanical test benches, and OCT equipment.
- Haptic preparation & verification for molding
- Deflashing of Lenses
- Cleaning of Lenses
- Assisting in validation protocol execution.
- With guidance from engineering, performs tests, gathers test data and records results in accordance with manufacturing requirements.
- Training of manufacturing personnel on manufacturing process
- Supporting process improvement initiatives to enhance production efficiency, as well as ensure business continuity and regulatory compliance.
- Employees may also train and be asked to execute activities beyond this job description, while working toward a certification of an already established job description within the department function. Said training will be documented in accordance with quality system requirements and added to employee file as record of achievement.
- Additionally, employee may be certified to lead a process or set of processes, once proving they have mastery of the area and meeting the following criteria. This role places a higher level of responsibility for the individual to ensure proper training, execution, and mastery of processes within the area assigned. This does not place the employee in a supervisory role.
- Employee must prove to embody the following values to be considered for a certification:
- Qualification in areas of responsibility
- Respect (for self and others)
- Teamwork
- Sense of Urgency
- Customer Focus
- Professionalism
- Interpersonal communication
- Problem Solving Ability
- Certification is contingent on the following:
- Management discretion to train and select individuals as needed.
Employees cannot have been involved in any human relations issue while at work within prior three months of petition for certification.
Requirements
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:
- Microscope use, handling, and assembly of microscopic parts. Prior work inside a cleanroom environment.
SUPERVISORY RESPONSIBILITIES:
- This job has no supervisory responsibilities.
EDUCATION, EXPERIENCE, and TRAINING:
- Minimum of associate degree or three to five years related experience and/or training; or equivalent combination of education and experience on medical devices.
- Employee Training is 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:
- This job does not require certification, licensing, or registrations aside from the training and certification provided by RxSight.
COMPUTER SKILLS:
- Baseline skills with Microsoft office applications (Word, Excel, Outlook, Teams), online spreadsheets (Smartsheet) and ERP system software (QAD) preferred.
