Director of Sustaining & Manufacturing Engineering

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 Director of Sustaining & Manufacturing Engineering will lead and oversee all aspects of the manufacturing engineering processes, ensuring efficient production, quality control, and compliance with industry standards. This role is critical for driving innovation, process improvements, and operational excellence within the company’s manufacturing operations in a mixed mode and repetitive methodology. This position will manage a staff of Manufacturing and Process Engineers bringing new products from development through full scale manufacturing with special emphasis on scaling and growth of operations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop and implement manufacturing engineering strategies that align with the company’s overall goals and global expansion.
• Lead a cross functional team of engineers and technicians to support new production introductions (NPI), process development, and continuous improvement initiatives.
• Drive innovation in manufacturing processes, equipment, and technology to ensure optimal production efficiency, quality, and cost-effectiveness with special emphasis on ROI analysis of projects before they commence.
• Ensure the team is educated on various industry standards and compliance metrics.
• Key project team lead interfacing with RD&E for new technology release and ensuring resources are assigned for transfer into Manufacturing.
• Ensure team is focused on gap analysis and ensuring all Work Instructions are governed with necessary process improvements with focus on ISO13485 and FDA compliance.
• Lead and support process validation (IQ, OQ, PQ).
• Implement and promote Lean Manufacturing (factory physics) principles methodologies to drive continuous improvement, including RedZone optimization and shop floor control.
• Conduct root cause analysis on process deviations, non-conformances, and equipment issues, and implement corrective and preventive actions.
• Working closely with RD&E, Quality, and Regulatory Affairs teams to ensure design for manufacturability and seamless transition from product development to full-scale production.
• Establish Key Performance Indicators (KPI) to monitor and report on manufacturing performance and process improvements.
• Build and mentor a high-performing team of engineers, providing leadership, guidance, and professional development opportunities.
• Allocate resources and manage the team’s workload to ensure timely completion of projects always based on priority matrix.
• Promote a culture of ownership, collaboration, and accountability within the team.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

• 10+ years of experience in Quality or Manufacturing engineering role, preferably within the medical device or regulated industry, with 5+ years in people management.

SUPERVISORY RESPONSIBILITIES:

• Must lead a diverse team of engineers focused on various products.
• Hands on experience and demonstrating a hands-on approach is essential to be successful for this position.

EDUCATION, EXPERIENCE, and TRAINING:

• BS in Mechanical Engineering or, Industrial Engineering or, Manufacturing Engineering.
• Six Sigma experience is highly desirable. Strong knowledge of engineering, process development and equipment validation.

CERTIFICATES, LICENSES, REGISTRATIONS:

• COMPUTER SKILLS:
• MS Office Products
• Spreadsheet software (SmartSheet preferred)
• Experience with CAD Software (SolidWorks) preferred