Senior Manufacturing Engineer

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 Senior Manufacturing Engineer will play a vital role in supporting and leading the sustaining efforts aimed at continuous improvement and maintaining robust manufacturing processes related to the Light Adjustable Lens and Insertion device manufacturing. As a vital member of the Manufacturing Engineering team, this individual will closely collaborate with Manufacturing, Design Engineering and Quality Control/Assurance departments to ensure production line sustainability, compliance with regulations, and quality systems requirements. The Senior Manufacturing Engineer will be responsible for deploying lean manufacturing methodology and implementing the culture of continuous improvement to improve overall safety, quality, on-time delivery, and productivity of our LAL and Insertion device manufacturing and processes. This individual will also guide and mentor the engineering team and other departments in resolving manufacturing and production issues, improving engineering and project systems, and identifying and resolving product or process issues.

Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Lead effort in support of continuous improvement initiatives aimed at enhancing production efficiency, ensuring business continuity, and maintaining regulatory compliance.
• Implement corrective and preventive actions for production non-conformances.
• Establish and execute validation strategies (IQ/OQ/PQ) for new processes, and equipment in compliance with ISO 13485 and FDA regulations.
• Implement corrective and preventive actions for production non-conformances.
• Provide troubleshooting expertise for equipment-related issues and offer technical support to operators and technicians as required.
• Initiate documents such as drawings, work instructions, and reports ensuring proper routing through the quality management system.
• Perform training necessary for the implementation of processes/tooling changes as necessary.
• Set up, operate, and maintain various manufacturing equipment and tools.
• Perform diagnostics, troubleshoot, and repair complex electrical, mechanical, network and software issues.
• Participate in root cause analysis and implement corrective actions for manufacturing issues.
• Perform analysis and provide input to mitigate risk due to obsolete or high-risk equipment and parts.
• Ability to stay on tasks with minimal supervision and minimal direction.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

• Demonstrates a hands-on approach to problem solving, ensuring prompt task closure.
• Familiarity with SolidWorks PDM software (desired).
• Proficient in conducting training sessions and initiating engineering change requests.
• Prior experience working in a cleanroom environment/ or medical device manufacturing is highly preferred.
• Experience with optical measurement systems (Keyence, NEMO, or similiar)
• Demonstrate strong problem-solving skills and can ask critical questions without being the subject matter expert.
• Professional, responsible, energetic, and accountable.
• Strong interpersonal skills – the ability to communicate effectively at multiple organizational levels including technicians, Engineering, Chemistry, and Production operators.
• Clear communicator – understands how to distill information to have substantive discussions with the right audience.
• Strong Organizational skills – the ability to balance and prioritize multiple studies, and manufacturing builds.
• Continued appetite to learn about our technology, its performance characteristics, and its manufacturing process – our process and our technology are unique!
• Self-motivated, proactive, and able to work effectively under minimal supervision.

EDUCATION, EXPERIENCE, and TRAINING:

• Bachelor’s degree in Biomedical, Electrical, or Mechanical Engineering with a minimum of 7 years of technical experience.
• Master’s degree in Biomedical, Electrical, or Mechanical Engineering with a minimum of 5 years of technical experience.
• Continuous improvement experience.
• Familiarity with regulatory standards (ISO 13485).
• Familiarity with good manufacturing practices (GMP) and good documentation practices (GDP). Experience with good laboratory practices (GLP) is a plus