Manufacturing Injector Cleanroom Lead (Mon-Fri 6:00am-2:30pm) bei RxSight, Inc.

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 Manufacturing Injector Cleanroom Lead reporting to the Injector Cleanroom Supervisor will focus on fully understanding the company's technology and the processes necessary to manufacture it. With an emphasis on understanding process requirements, timing, cadence, training, available talent and application in real-time manufacturing. After training on manufacturing procedures, the Injector Cleanroom Lead can coordinate the execution of all processes to maintain production flow to meet company production quotas, timelines, and quality standards. The Injector Cleanroom Lead performs planning, coordination, and organization of daily manufacturing activities. Responsibilities include LAL packaging, accessories as well as special adhoc projects relating to manufacturing. A critical component of this position is maximizing the LAL sterile loads both from a maximum quantity and timing standpoint. Direct communication and support with supervisor.

Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The Injector Cleanroom Lead will interact with the other functions including but not limited to Engineering, Quality, Chemist and R&D. It is expected that this individual will have the depth and breadth of experience to contribute to the oversight of the overall manufacturing of the LAL lenses.

• The Manufacturing Injector Cleanroom Lead will interact with the other functions including but not limited to Engineering, Quality, Warehouse and Planning. It is expected that the lead will have the depth and breadth of experience to contribute to the overall processing of injectors and cartridges. The lead must complete the work with the highest Quality standards possible within the allowed time given to maintain the highest efficiencies.
• Coordinates and communicates the execution of the following activities, to meet production goal timelines:
• Oversees and supports the execution of:

MICA III Cleanroom Activities:

• Component Cleaning & Inspection
• ERP system (QAD) work order data entry and closure

MICA II Activities

• Micro-Abrasion
• Abrasive Sieving
• Cartridge Label Production

MICA I Activities

• Component Assembly
• Component Sealing
• Packaging Assembly

• The Lead may also be certified to train in the above activities.
• Is responsible for collaborating and publishing a high-level weekly task plan for manufacturing activities.
• Coordinates training of personnel to meet production goal timelines.
• Coordinates production assistance in validation protocols, execution.
• With guidance from engineering, perform tests, gather test data and records results in accordance with manufacturing requirements.
• Support process improvement initiatives to enhance production efficiency, as well as ensure business continuity and regulatory compliance.
• The Injector Cleanroom Lead may also be certified to train in the activities.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

• Past Medical Device Packaging Experience.
• Demonstrated ability to develop and implement Processes.

SUPERVISORY RESPONSIBILITIES:

• This position has a large team of Injector Cleanroom Associates with varying skill levels.

EDUCATION, EXPERIENCE, and TRAINING:

• Three to five years related experience and/or training; experience in medical device packaging.
• 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:

• 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.

Notice to Staffing Agencies and Search Firms:

RxSight does not accept unsolicited resumes or candidate submissions from staffing agencies or search firms for any employment opportunities. All agency engagements must be authorized in writing for a specific position by RxSight’s Talent Acquisition department. Any resumes or candidate information submitted without such specific engagement will be considered unsolicited and the property of RxSight. No fees will be paid in the event a candidate is hired under these circumstances.