Senior Director, Manufacturing Operations

About The Role

We are seeking an accomplished Senior Director of Manufacturing Operations to lead all aspects of our U.S.-based facility specializing in the production of RGP lens buttons and finished lenses. This is a pivotal leadership role with full operational responsibility, overseeing polymer production, precision button machining, and advanced manufacturing processes for customized scleral and Ortho-K lenses. The ideal candidate will 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:
• 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 the Global VP, Operations to develop and execute long-term strategies for capacity expansion and new product introduction

• Button Manufacturing:

• Precision Lens Machining:

• Lens Finishing & Quality Control:

• Oversee thermal polymerization using proprietary heated curing ovens
• Manage precision CNC machining of polymer rods into optical-grade button blanks
• Supervise safe, controlled mixing of monomers under vented fume hoods per custom formulations
• Oversee post-lathing polishing, edge-finishing, hydration, inspection, and marking
• Ensure traceability, labeling, and packaging meet regulatory and customer requirements 
• Coordinate cleanroom manufacturing standards
• 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

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 workforce including polymer technicians, CNC machinists, and QA staff
• 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

• 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
• 8+ 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