Technical Lead, Manufacturing Line

Reference: 631181

Provides technical leadership for production line to ensure safe, compliant, efficient, and reliable manufacturing operations. This role serves as the primary engineering lead responsible for process validations, process performance, equipment reliability, product quality, capacity expansion, and continuous improvement initiatives. They collaborate cross-functionally with Operations, Quality, Supply Chain, Research & Development, Regulatory Affairs, and Manufacturing Engineering teams to support commercial production, new product introductions and operational excellence objectives. Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. Lead process validations, equipment qualifications, and implementation of manufacturing changes in compliance with regulatory requirements. Partner with Operations and Quality teams to ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and company procedures. Identify and mitigate technical risks impacting safety, quality, delivery, or manufacturing continuity. Support new product introduction (NPI) activities, including process development, line readiness, technology transfer, and manufacturing scale-up. Provide technical oversight for capital equipment projects, automation initiatives, and facility upgrades. Analyze and report manufacturing performance metrics like LBM, yield, capacity and develop action plans to improve throughput, efficiency, and overall equipment effectiveness (OEE).Serve as the primary technical escalation point and owner for technical strategy, operational performance, product launch and hypercare of the manufacturingline.* Mentor and guide manufacturing engineers, process engineers, and cross-functional team members"