LAL Process Engineer
RxSight, Inc. - aliso viejo, CA
Apply NowJob 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. Reporting to the Director of LAL manufacturing will be responsible optimizing and improving our manufacturing processes for intra-ocular lenses, packaging and accessories. You will be responsible for ensuring the efficiency, quality, and safety of our production processes while driving continuous improvement initiatives. Your expertise will be essential in instilling a process engineering focused culture at RxSight. Requirements ESSENTIAL DUTIES AND RESPONSIBILITIES: Process Optimization: Continuously evaluate and improve manufacturing processes to enhance efficiency, reduce costs, and ensure the highest product quality. (Evaluation and initiation of projects). Identify and present cost-saving opportunities through process improvements, waste reduction, elimination of process variability, and resource optimization. Process Transfer: Participate in manufacturing process, equipment, tooling transfer & monitoring activities to ensure streamlined implementation, identify and enforce best practices, and assisting in training production personnel on new processes. Process Continuation Efforts: Ensure process, equipment and tooling continuity ensuring proper functionality, practicality, reliability and usability throughout life cycle. Process Capacity: Continuously monitor and analyze production process capacity. Measure standard work timing. Data Analysis: Collect and analyze process data to identify trends, root causes of issues, and opportunities for improvement. Implement data-driven solutions to enhance process performance. Documentation: Create and maintain detailed process documentation, including standard operating procedures (SOPs), pFMEAs, process flowcharts, job aids and equipment manuals. Collaboration: Work closely with cross-functional teams, including R&D, quality control, and production, to facilitate product development, manufacturability and process scale-up. Quality Assurance: Collaborate with the quality control team to establish and maintain quality standards, ensuring compliance with regulatory requirements and industry best practices. (Considering compliance towards efforts) REQUIRED KNOWLEDGE, SKILLS AND ABILITIES: Familiarity with regulatory requirements and quality standards in the medical device industry (e.g., ISO 13485). Excellent problem-solving skills and the ability to work effectively in a team-oriented environment. Strong communication and project management skills. Attention to detail and a commitment to delivering high-quality results. SUPERVISORY RESPONSIBILITIES: This position has no supervisory responsibilities. EDUCATION, EXPERIENCE, and TRAINING: Bachelor's degree in engineering, or a related field (master's degree preferred). Proven experience in process engineering within a manufacturing environment, ideally in medical device manufacturing. Strong knowledge of lean manufacturing principles and continuous improvement methodologies (e.g., Six Sigma, 5S, Kaizen). Familiarity with FDA Code of Federal Regulations Part 820, ISO 13485 Strong preference for a minimum of 5 years in the medical device industry. Training to be completed per the training plan for this position as maintained in the document control system. CERTIFICATES, LICENSES, REGISTRATIONS: None COMPUTER SKILLS: Word Processing Spreadsheet Software Data Analysis Salary Description 90,000 - 105,000
Created: 2024-10-14