Senior Director, Manufacturing

• ✓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

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

• ✓Must be able to remain in a stationary position for extended periods of time
• ✓Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
• ✓Ability to work on the manufacturing floor, including in gowned/cleanroom environments, for extended periods of time

• ◆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

• ✓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

• ✓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
• ✓Other

may be assigned & not all

listed may be assigned

• ◆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
• ◆Other

may be assigned, not all

listed may be assigned

Nearest Major Market: Cincinnati

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