To provide leadership and direction to the manufacturing facility in a manner that ensures the operation meets or exceeds customer requirements as well as all quality, safety and regulatory requirements.
Job Duties:
•Manage and coordinate all facility operations to meet customer order requirements, control costs and meet quality and regulatory requirements while maintaining operational effectiveness and efficiency.
•Oversee overall facility operations to include manufacturing, materials management, quality, finance, human resources, information systems, manufacturing engineering and all support operations.
•Coordinate the product development process and ensures product launch schedules are met.
•Ensure performance of and monitors key business indicators.
•Develop budgets, monitor expenditures and control costs related to manufacturing operations.
•Develop an effective organization through hiring, termination, and training of employees.
•Develop, recommend and implement system and process improvements to production activities including costing, scheduling, materials management, and QC.
•Participate as a key contributor to strategy development and execution.
•Ensure that all necessary systems, standard operating procedures and policies are in place and followed by all employees and that all company activities are in compliance with applicable laws.
Qualifications :
•Must possess a 4 year Bachelor’s degree in an Engineering or Technical area; MBA preferred.
•At least 15 years of experience in medical device, with at least 5 years of operations experience with P&L responsibility.
•Experience in a manufacturing environment with strong regulatory and quality requirements is required; must possess knowledge of and understand ISO, QSR/GMP and FDA requirements.
•Experience in manufacturing, engineering and product development of OEM products required; experience in extrusions, over molding, design controls and guide wires highly preferred.
•Must have experience developing and managing budgets and be able to read, understand and interpret financial statements.
•Must have experience in establishing, implementing and maintaining internal controls, preferably in a public company environment.
