RxSight, Inc.
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Senior Manufacturing Engineer
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RxSight, Inc. 1 day ago Be among the first 25 applicants Join to apply for the
Senior Manufacturing Engineer
role at
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 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. Job Type
Full-time
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. 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
Microsoft Word; Microsoft Excel; Teams MiniTab Project Management System (SmartSheet preferred) CAD (SolidWorks or PRO/E proficiency 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.
Salary Description
$100,000 To $130,000 Per Year Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
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Senior Manufacturing Engineer
role at
RxSight, Inc. 1 day ago Be among the first 25 applicants Join to apply for the
Senior Manufacturing Engineer
role at
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 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. Job Type
Full-time
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. 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
Microsoft Word; Microsoft Excel; Teams MiniTab Project Management System (SmartSheet preferred) CAD (SolidWorks or PRO/E proficiency 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.
Salary Description
$100,000 To $130,000 Per Year Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at RxSight, Inc. by 2x Get notified about new Senior Manufacturing Engineer jobs in
Aliso Viejo, CA . Irvine, CA $93,195.00-$155,514.00 2 weeks ago Senior Manufacturing Engineer - Wire Harnesses
Senior Plant Manager, Medical Device Custom Manufacturing
Corona, CA $175,000.00-$190,000.00 6 days ago Costa Mesa, CA $128,000.00-$192,000.00 1 day ago Manufacturing Manager - Operations, Selution
Irvine, CA $111,650.00-$159,500.00 1 month ago Manufacturing Manager - Bioprosthetic Devices
Irvine, CA $150,000.00-$170,000.00 2 weeks ago Irvine, CA $111,288.00-$139,105.00 2 days ago Architecture Sr. Design Manager- Food & Beverage Manufacturing
Fullerton, CA $120,000.00-$160,000.00 1 week ago Manager, Manufacturing Operations - Connected Warfare
Santa Ana, CA $130,000.00-$190,000.00 1 week ago Architecture Design Manager- Food & Beverage Manufacturing
Fullerton, CA $90,000.00-$140,000.00 5 days ago Lake Forest, CA $85,000.00-$95,000.00 1 week ago Placentia, CA $100,000.00-$120,000.00 1 week ago Life Sciences - Manufacturing AI Solutions, Manager
Costa Mesa, CA $130,800.00-$241,000.00 6 hours ago Corona, CA $115,000.00-$135,000.00 13 hours ago Manufacturing Operations Manager (food/beverage manufacturer)
Corona, CA $145,000.00-$155,000.00 1 week ago Process Engineer - Practice Leader - Biosolids/Residuals
Associate Brand Manager - Food Manufacturing
Sr. IT Manufacturing Applications Manager (D365)
Irvine, CA $165,000.00-$180,000.00 3 weeks ago Santa Ana, CA $75,000.00-$77,000.00 1 week ago Senior Supply Chain Manager / Senior Procurement Manager
Investment Castings (Aerospace Manufacturing)
Santa Ana, CA $170,000.00-$215,000.00 2 weeks ago Corona, CA $150,000.00-$160,000.00 3 weeks ago Senior Manufacturing Engineer - New Product Introduction (NPI)
Sr Manufacturing Engineer (Injection Molding)
San Clemente, CA $116,954.00-$141,515.00 1 month ago Senior Manufacturing Engineer - Avionics
Irvine, CA $110,000.00-$135,000.00 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr