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Senior Manufacturing Manager, Instruments Jobs

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Senior Manufacturing Manager, Instruments
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Lead instrument manufacturing for IVD and research markets in Austin, TX. This senior role requires a BS in Engineering, 10+ years in electromechanical assembly, and 8+ years in operations leadership. You will ensure cGMP compliance, manage financial performance, and drive new product introductio...
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United States , Austin, Texas
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Not provided
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Diasorin
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Until further notice
A Senior Manufacturing Manager for Instruments is a pivotal leadership role at the heart of producing sophisticated electromechanical devices, such as those used in medical diagnostics, laboratory research, and industrial settings. This profession involves overseeing the end-to-end manufacturing process for complex instrument portfolios, ensuring that products are not only built to exacting specifications but are also safe, effective, and compliant with stringent regulatory standards. Professionals in these jobs bridge the gap between engineering design and volume production, transforming prototypes into reliable, commercially viable products. They are accountable for the operational and financial performance of their manufacturing unit, managing teams, budgets, and continuous improvement initiatives to meet demanding business objectives. The common responsibilities of a Senior Manufacturing Manager, Instruments, are multifaceted. Typically, they provide direct leadership to supervisory and production staff, fostering a culture of quality, safety, and efficiency. A core duty is developing and executing production plans to fulfill demand, which involves meticulous resource planning for personnel, equipment, and facility infrastructure. They ensure all manufacturing activities adhere to rigorous quality management systems, such as ISO 13485 and FDA regulations for medical devices. A significant part of the role involves driving design transfer for new product introductions (NPI) and product changes, working closely with Manufacturing Engineering to ensure production readiness. Furthermore, they are charged with implementing lean manufacturing and continuous improvement (CI) projects to eliminate waste, reduce costs, and enhance operational flexibility, while also managing key performance indicators (KPIs) and variance analysis. Typical skills and requirements for these leadership jobs are substantial. Candidates generally possess a Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or a related scientific field, often supplemented by an advanced degree. A minimum of 8-10 years of progressive experience in an electromechanical manufacturing environment, with at least 5-8 years in direct operational leadership, is standard. Expertise in a regulated industry, particularly medical devices (FDA, ISO 13485), is highly preferred. Essential skills include thorough knowledge of design control, process validation (IQ/OQ/PQ), and statistical process control (SPC). Proficiency in Manufacturing Resource Planning (MRP) and Enterprise Resource Planning (ERP) systems like SAP or Oracle is valuable. Successful managers demonstrate strong financial acumen for budgeting and cost management, proven problem-solving abilities using data-driven tools, and excellent people management skills to hire, develop, and mentor high-performing teams. For those seeking to lead at the intersection of precision engineering and scalable production, Senior Manufacturing Manager, Instruments jobs offer a challenging and rewarding career path driving innovation and operational excellence.

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