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 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