Senior Manager, Manufacturing Operations

About the Role

We are seeking a senior manager, 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

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