Senior Director, Manufacturing

Enable Injections Inc. • Sharonville, OH

1d • Onsite

About The Position

This role is responsible for developing Enable's manufacturing strategy and owning Manufacturing and Facilities, including all shop floor activities, ensuring safe, compliant, and efficient operations. The position involves working with Engineering and Product Development to implement a capital equipment and manufacturing capacity plan, executing build plans to assure adequate product supply, and developing overall manufacturing plans, budgets, and objective metrics. The Senior Director will lead the manufacturing organization with a clear vision, motivate a high-performance team, and supervise direct reports. Key responsibilities include owning CAPA, risk management, and process validation activities, assessing and improving manufacturing systems using Lean Manufacturing and Six Sigma, and maintaining manufacturing metrics. Additionally, the role involves developing and delivering EH&S training, tracking EH&S metrics, supporting ergonomics and industrial hygiene, maintaining OSHA recordkeeping, serving as a contact for regulatory inspections, supporting environmental compliance, and championing a proactive safety culture.

Requirements

• Bachelor's degree with a preference in Engineering, or equivalent combination of education and experience
• 15 years of disposable medical device manufacturing experience in high-volume, medium-to-complex operations
• A track record of successfully organizing and building fully functioning manufacturing and shop floor operations capable of growing and optimizing production capacity
• Knowledge of current regulatory requirements for GMP/GDP, including FDA's Quality Management System Regulation (QMSR) and ISO 13485
• Strong knowledge of manufacturing metrics
• Strong People Development skills
• Strong Project Management skills
• Managing and developing others

Nice To Haves

• Master's degree
• 20+ years of medical device manufacturing experience
• Combination product experience
• Six Sigma Black Belt or demonstrated continuous improvement skill set
• Equipment maintenance and validation experience in a regulated environment
• Budgeting, ERP and inventory management experience
• Experience with automated equipment and common product and device assembly methods
• Demonstrated experience leading manufacturing operations through a period of significant company growth
• Direct experience supervising manufacturing floor operations and operators

Responsibilities

• Work with senior management to develop Enable's manufacturing strategy
• Participate in development of company business systems & work environment
• Own Manufacturing and Facilities, including all shop floor activities, ensuring safe, compliant, and efficient operations
• Work with Engineering and Product Development to implement a capital equipment and manufacturing capacity plan
• Execute build plans to assure adequate product supply to meet forecasted requirements
• Develop overall manufacturing plans, budgets & ensure execution
• Develop easily understandable and specific objective metrics for positions, stations and overall floor operations
• Increase yield and capacity and decrease overall COGs
• Lead the manufacturing organization, including all shop floor operations, with a clear, direct vision
• Ensure team leaders develop achievable work plans
• Motivate and lead a high-performance manufacturing and shop floor team
• Supervise, develop, mentor and coach direct reports in maximizing their talent and career potential
• Own CAPA, risk management, and process validation activities for manufacturing and shop floor operations, ensuring compliance with FDA QMSR, ISO 13485, and GMP/GDP requirements
• Assess efficiency of product manufacturing systems; develop & implement improvement plans utilizing Lean Manufacturing and Six Sigma methodologies
• Maintain and update manufacturing metrics to track safety, quality, quantity, delivery and cost information
• Develop, deliver, and own EH&S training for new hire onboarding and ongoing employee education
• Track, analyze, and report EH&S metrics (TRIR, near-misses, corrective actions) to site and executive leadership
• Lead or support ergonomics assessments and industrial hygiene monitoring (noise, air quality, chemical exposure)
• Maintain OSHA recordkeeping (Forms 300, 300A, 301) and ensure timely regulatory reporting
• Serve as primary point of contact for EH&S regulatory agency inspections and audits
• Support environmental compliance programs, including waste management, air permits, and stormwater management
• Champion a proactive safety culture through employee safety committees and recognition programs
• Support corporate Vision and manage using the corporate values

What This Job Offers

• Job Type: Full-time
• Career Level: Senior