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POSITION SUMMARY The Engineering Senior Manager provides strategic engineering leadership across four core functional areas: Program Management, Manufacturing Engineering, Process Development, and Operational Excellence. This leader is responsible for building and executing engineering strategies that advance process capability, accelerate new product introduction (NPI), and develop a high-performing technical talent pipeline in a regulated medical device environment. The ideal candidate brings deep hands-on expertise in injection molding, extrusion, and electronics/electromechanical systems, combined with a strong command of quality systems and regulatory requirements applicable to sterile-use medical devices including catheters and fluid delivery systems. This role operates in a fast-paced, globally integrated environment and demands a leader who is equally effective on the manufacturing floor and as well as in leadership forums. KEY RESPONSIBILITIES Program Management •       Lead and govern cross-functional engineering programs through commercial launch, ensuring on-time, on-budget, and on-quality delivery. •       Establish and maintain program governance frameworks, milestone reviews, risk registers, and escalation pathways. •       Coordinate engineering resources across internal teams and external development partners, and suppliers. •       Partner with quality and R&D to ensure all programs meet applicable regulatory requirements (FDA 21 CFR Part 820, ISO 13485, MDR, etc.). •       Report program status and engineering KPIs to senior leadership on a regular cadence. Manufacturing Engineering •       Provide technical oversight and strategic direction for all manufacturing engineering activities supporting electromechanical and single-use sterile medical devices including catheters and fluid delivery systems. •       Drive process validation (IQ/OQ/PQ), equipment qualification, and process control strategies in accordance with design control and GMP requirements. •       Lead engineering input into facility layout, capital equipment planning, and manufacturing capacity strategy. •       Ensure manufacturing processes are repeatable, scalable, and compliant with applicable standards. •       Own technology transfer from development to full-scale manufacturing, including documentation, training, and capability demonstration. Process Development •       Develop and optimize core manufacturing processes with emphasis on: Injection molding (thermoplastics, LSR, insert molding, overmolding) Extrusion (catheter tubing, multi-lumen, co-extrusion) Electronics assembly and electromechanical integration Catheter assembly, tip forming, bonding, and sterile barrier systems Fluid delivery system assembly and testing •       Apply statistical methods (DOE, SPC, Cpk/Ppk analysis, FMEA) to develop robust, capable processes. •       Lead process capability development initiatives that systematically reduce variation and improve yield. •       Collaborate with R&D and Product Development to ensure designs are optimized for manufacturability (DFM/DFA). •       Maintain current knowledge of emerging process technologies and drive appropriate adoption. Operational Excellence •       Champion a culture of continuous improvement using Lean, Six Sigma, and related methodologies across the engineering organization. •       Define and track operational metrics