The Director of Manufacturing will be responsible for directing a team of Group Leaders, Assemblers, and Technicians in a controlled manufacturing environment, including talent assessment, current and future organizational structure, and broad departmental oversight and support. This person will be a hands-on leader with proven ability to build an organization and strive towards performance excellence as it pertains to assembl y, test, and final packaging of medical devices in conformance to established standards. She/he will be responsible for all Manufacturing activities; interfacing with and peers from all cross functional departments including Quality, Materials Management, R&D, and Finance. Essential Duties and Responsibilities include the following - Providing direction and administrative support for a team comprising of Group Leaders, Manufacturing Assemblers and Technicians. Maintaining daily production schedule, including monitoring staffing and overtime requirements. Assuring team’s efforts are in full compliance with company Quality policies, ISO and other relevant regulations, company SOP’s and manufacturing procedures. Proposing and implementing functional strategies and manufacturing objectives in alignment with overall company goals. Overseeing assembler training and performance attainment in the following areas – Assembling components into complex sub-assemblies ; Performing intermediate assembly tasks such as trim m ing, polishing, sanding, cleaning, bonding, curing, etc. Packaging products in preparation for sterilization processing. Reviewing documentation including DHR’s, pouch and box labels, and inspection forms in advance of assembly, packaging, and sterilization operations. W orking with Manufacturing Engineering Manager to – Drive process improvements Ensure all equipment is properly set up and calibrated Confirm required technical support for process and equipment efficiency and accuracy. Working with Supply Chain Manager to ensure adequate supply of component and raw material inventory to support production schedule. Communicating regularly to VP Operations all pertinent manufacturing, quality, and administrative activities. Additional tasks and responsibilities as assigned. Qualifications and Core Competencies Bachelor's degree (Engineering or Operations Management discipline preferred). Advanced degree a plus. Minimum of ten years’ experience in a regulated medical device manufacturing environment (at least five of which is in a management role). Proven ability to make difficult decisions and e xhibit sound judgment. Prioritize and plan work activitie s efficiently; s et effective (SMART) goals and objectives. Thorough knowledge of QSR, ISO 13485, and MDD as relatable to a medical device manufacturing environment. Excellent communication skills (verbal and written) required.