General Description: Owns the manufacturing client experience from the time the project is introduced to the manufacturing floor through final part or assembly shipment. Responsible for providing input to mold design to ensure successful sampling and production. Responsible for the overall success and development of Omega’s manufacturing operations team; this includes all resources utilized to develop repeatable processes, molded parts, and assemblies in a compliant, safe, productive, and profitable environment. Provides the strategic development and evolution of medical device manufacturing including development of volume production and assembly processes. Responsible for the profitability, quality, and timeliness of the manufacturing operations. This is accomplished through approximately 70% of daily on-the-floor interaction. Specific Responsibilities: + Uphold and communicate the purpose, principles, and vision of Omega Plastics. + Responsible to implement the daily schedule, communicate unresolvable issues to Program Managers + Ensure shift leads are hitting cycle times, reporting properly on good product, scrap and non-conforming product + Direct Process Techs and Engineers for new samplings, technical consulting, problem resolution and schedule + Escalate immediately to the Director of Operations on jobs that are not going to meet the committed daily schedule + Responsible for training and leadership development of direct reports – includes staffing, recommendations, effective and timely training + Initiate and complete CCR’s and SCC’s for improvements to Work Order Instructions and/or Process improvements + Responsible for direct report’s compliance for all batch history records for medical molding and assembly operations + Daily rack-up with direct reports to ensure alignment of schedule priorities and issue resolution + Ensure that appropriate systems and structures are in place to produce, package and release acceptable medical device product in accordance with GMP, GDP, FDA and client requirements + Coordinate with the Quality Manager and Quality Assurance Teams to ensure quality levels of product meet expectations and to support CAPA’s + Provide Engineering support of new projects (processes, protocols, work instructions etc.) + Ensure Departmental compliance to Omega BQMS + Safety and cleanliness of manufacturing work environment (compliant with state & federal requirements) + Train team on lean, 5s, and appropriate best-in-class manufacturing processes that adhere to FDA regulations and ISO13485 requirements to cultivate an environment of continuous improvement + Drive Medical CAPA’s and NCR’s to closure + Optimize cycle time and efficiencies through the addition of cobots, automation and end-of-arm tooling. + Other specified duties as required by the General Manager Benefits and Compensation: Medical Insurance and Prescription Drugs Dental Insurance Vision Insurance Flexible Spending Accounts Basic Life and AD&D Insurance Voluntary Term Life and AD&D Insurance Basic Short-Term Disability Basic Long-Term Disability Insurance (for eligible employees) Employee Assistance Plan (EAP) Comprehensive Wellness Program Voluntary Critical Illness and Accidental Injury Insurance Paid Time Off (Includes vacation and sick time) Retirement Program Optional Life Insurance Optional Long-Term Disability Other Voluntary Benefits Profit Sharing Bonus Compensation: $112,000 - $124,000