Bachelor's degree in Engineering or equivalent experience
15 years in high-volume medical device manufacturing
Proven ability to build and optimize manufacturing operations
Knowledge of FDA QMSR and ISO 13485
Strong understanding of manufacturing metrics
Expertise in people development and project management
Experience in managing and developing teams
Responsibilities
Collaborate with senior management to set manufacturing strategy
Participate in creating business systems and work environments
Oversee manufacturing and facilities for safe and efficient operations
Coordinate with engineering for capital equipment and capacity planning
Implement build plans to meet product supply forecasts
Develop manufacturing plans and budgets for execution
Create specific metrics for shop floor operations
Drive yield improvement and cost reduction initiatives
Lead and inspire a high-performance manufacturing team
Mentor and coach team members for career growth
Ensure compliance with CAPA, risk management, and process validation standards
Evaluate and optimize manufacturing efficiency using Lean and Six Sigma
Maintain metrics for safety, quality, and cost performance
Conduct EH&S training and manage compliance reporting
Engage in ergonomic assessments and safety culture initiatives
Benefits
Opportunities for professional development and growth
Engagement in a dynamic and high-growth environment
Collaborative work culture emphasizing safety and compliance
Involvement in innovative manufacturing practices
Mentorship and leadership opportunities within the team
Full Job Description
Location: Onsite
Status Type: Full Time
QUALIFICATIONS
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 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 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)
