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Senior Director, Manufacturing (Cincinnati, OH, US, 45241)

Senior Director, Manufacturing (Cincinnati, OH, US, 45241)

cintrifuseDayton, OH

today

Industrial Production ManagersFirst-Line Supervisors of Production and Operating WorkersQuality Control Systems Managers
Electromedical and Electrotherapeutic Apparatus ManufacturingSurgical and Medical Instrument ManufacturingOther Measuring and Controlling Device Manufacturing
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Location: OnsiteStatus Type:
Full TimeQUALIFICATIONS
Required:
  • 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
Preferred:
  • 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
  • Skills & Competencies:
  • Familiarity with Clean Room Environments
  • Lean Manufacturing and continuous improvement methodologiesCAPA (Corrective and Preventive Action) process ownership
  • Risk Management (e.g., ISO 14971) applied to manufacturing processes
  • Process Validation (IQ/OQ/PQ) methodology
  • Identifying and 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 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 timeRESPONSIBILITIES: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 COGsLead 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
  • 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

Also on the board Same function, level within a rung

Level

Manager

Location

Dayton, OH

Occupation

Industrial Production Managers

Industry

Electromedical and Electrotherapeutic Apparatus Manufacturing

Posted

today

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