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Job description
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Bachelor's degree with a preference in Engineering,or equivalent combination of education and experience
15 years ofdisposablemedical device manufacturing experience in high-volume, medium-to-complex operations
A track recordof successfully organizing and building fully functioning manufacturing and shop floor operations capable of growing andoptimizingproduction 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
Managing and developing others
Preferred:
20+ years of medical device manufacturing experience
Six Sigma Black Belt ordemonstratedcontinuous improvement skill set
Equipment maintenance and validation experience in a regulated environment
Budgeting,ERPand 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
Familiarity with Clean Room Environments
Lean Manufacturing and continuous improvement methodologies
CAPA (Corrective and Preventive Action) process ownership
Risk Management (e.g., ISO 14971) applied to manufacturing processes
Process Validation (IQ/OQ/PQ)methodology
Identifyingand developing manufacturing and shop floor talent
Production Operation Staffing and Scheduling
Verbal and written communication
Developing effective technical and business presentations
Managing resources in a dynamic, high-growth environment
Physical Requirements:
Must be able to remain in a stationary position for extended periods of time
Ability to constantlyoperatea computer and other office equipment, such asprinter,telephone, etc.
Ability to work on the manufacturing floor, including ingowned/cleanroom environments, for extended periods of time
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 buildplans toassureadequate product supply to meet forecasted requirements
Develop overall manufacturing plans, budgets & ensure execution
Develop easily understandable and specific objective metrics for positions,stationsand 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 plansutilizingLean Manufacturing and Six Sigma methodologies
Maintain and update manufacturing metrics to track safety, quality, quantity,deliveryand cost information
Other responsibilities may be assigned & not all responsibilities 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 responsibilities may be assigned, not all responsibilities listed may be assigned
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Worksite address
cincinnati, OH, 45208, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.