Senior Director, Manufacturing

Enable Injections, Inc.; Cincinnati (OH); On-site; USD 180,000 - 260,000; Full time

Job summary

Enable Injections, Inc. is seeking a Senior Director of Manufacturing onsite in Cincinnati to lead all shop floor operations, ensuring safe, compliant, and efficient production. You will own capital planning, capacity expansion, and supplier collaboration with Engineering and Product Development.

The role requires deep experience in high-volume medical device manufacturing, GMP/GDP standards, and a proven track record in leading growth while developing a high-performing team.

Qualifications

• Bachelor's degree in engineering or an equivalent combination of education and experience.
• 15 years of disposable medical device manufacturing experience in high-volume ops.
• Proven ability to scale and optimize shop floor capacity.
• Knowledge of GMP/GDP, FDA QMSR, ISO 13485 requirements.
• Strong manufacturing metrics and data-driven decision making.
• Proven people development and cross-functional leadership.
• Experience with capital projects, budgeting, and ERP systems.

Responsibilities

• Develop Enable's manufacturing strategy with senior management.
• Own Manufacturing and Facilities, ensuring safe, compliant operations.
• Collaborate with Engineering to implement capacity plans and capital equipment.
• Execute build plans to meet forecasted product supply.
• Create and manage manufacturing budgets and tracking metrics.
• Set clear objectives for stations and floor teams with measurable KPIs.
• Increase yield, capacity, and reduce overall costs of goods.
• Lead the manufacturing organization with a clear, actionable vision.
• Develop leaders and coach direct reports for career growth.
• Ensure CAPA, risk management, and validation activities comply with FDA QMSR and ISO 13485.
• Maintain and monitor safety, quality, delivery, and cost metrics.
• Support EH&S programs and regulatory inspections.

Skills

Lean Manufacturing

CAPA

Risk Management (ISO 14971)

Process Validation (IQ/OQ/PQ)

People Development

Production Planning & Scheduling

Verbal & Written Communication

Team Leadership

Data & Metrics Mindset

Education

Bachelor's degree in Engineering or equivalent

Master's degree (preferred)

Job description

Title: Senior Director, Manufacturing

Location: Onsite

Status Type: Full Time

Qualifications

• 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 methodologies
• CAPA (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 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 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
• 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

Nearest Major Market: Cincinnati