Director, Manufacturing Operations

6 days ago

Sterling, VA, United States Euclid Vision Corporation Full time
About the Role

We are seeking a director, manufacturing operations to partner with operational leaders to manage all aspects of our U.S.-based facilities specializing in the production of RGP lens buttons and finished lenses. This is an important hands-on role and will partner with operational leaders, overseeing polymer production, precision button machining, and advanced manufacturing processes for customized scleral and Ortho-K lenses. The ideal candidate will help drive excellence in safety, quality, delivery, and cost, while ensuring strict compliance with FDA, ISO 13485, and global regulatory standards.

Key Responsibilities

Operational Leadership

  • Direct all manufacturing operations across three core production streams:
    • Button Manufacturing:

      • Supervise safe, controlled mixing of monomers under vented fume hoods per custom formulations
      • Oversee thermal polymerization using proprietary heated curing ovens
      • Manage precision CNC machining of polymer rods into optical-grade button blanks
    • Precision Lens Machining:
      • Lead high-precision lathing of RGP buttons into finished scleral and Ortho-K lenses using CNC and diamond-turning equipment
      • Ensure exacting control of base curves, peripheral designs, and other geometries Monitor process capability and maintain tight tolerances
    • Lens Finishing & Quality Control:

      • Oversee post-lathing polishing, edge-finishing, hydration, inspection, and marking
      • Ensure traceability, labeling, and packaging meet regulatory and customer requirements
      • Coordinate cleanroom manufacturing standards
  • Drive integration and standardization of processes across product streams to maximize efficiency and leverage shared resources
  • Champion the adoption of digital and automated manufacturing tools
  • Partner with Global Operations to develop and execute long-term strategies for capacity expansion and new product introduction
Quality & Compliance
  • Ensure compliance with 21 CFR Part 820 (QSR), ISO 13485, and applicable global regulations
  • Collaborate with Quality and Regulatory teams to manage CAPAs, NCRs, audits, and inspections
  • Enforce documentation, batch records, change control, and validation protocols; review and approve all Engineering Release Authorization documents
People & Team Management
  • Lead and develop a skilled operational and manufacturing workforce
  • Directly manage a small team of product line SMEs, ensuring technical excellence
  • Promote a culture of safety, quality, Lean manufacturing, Six Sigma, and continuous improvement
  • Facilitate training on GMP procedures and SOPs; lead change management initiatives to foster a unified culture and smooth integration of teams
Engineering & Maintenance
  • Oversee maintenance and calibration of critical production equipment and measuring systems
  • Drive process optimization and capacity improvements; provide leadership on root cause analysis and timely resolution
  • Collaborate with Engineering and R&D for process development and validation
Financial & Operational Planning
  • Partner with operational leadership to manage site-level budgets, KPIs, and operational efficiency
  • Identify opportunities, develop, and execute improvement plans to achieve site targets; monitor production yields, scrap rates, and cycle times
  • Work with Supply Chain for inventory management and demand fulfillment Ensure operations are aligned with customer requirements and support rapid response to feedback
Qualifications

Required:
  • Bachelor’s degree in mechanical, chemical, industrial engineering, or related technical field
  • 5+ years in manufacturing leadership, including precision machining and/or medical device manufacturing
  • 3+ years in an FDA-regulated or ISO 13485-certified environment
  • Knowledge of polymer processing and CNC machining
Preferred:
  • Experience in manufacturing RGP, Ortho-K, or scleral contact lenses
  • Knowledge of diamond-turning, optical lathing, or lens design software
  • Lean Six Sigma certification or continuous improvement background
Key Competencies:
  • Strong leadership and team building in a regulated environment
  • Technical acumen in high-precision manufacturing
  • Data-driven decision making
  • Excellent communication and project management skills
  • Dedication to quality, safety, and regulatory compliance


Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.

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