Engineering Senior Manager

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 (OEE, yield, cycle time, COPQ, scrap rates) and drive performance improvement initiatives.
• Lead kaizen events, value stream mapping, and root cause/corrective action (CAPA) efforts.
• Partner with Quality and Operations to build a sustainable quality management system aligned with ISO 13485 and FDA QSR requirements.
• Identify and eliminate waste across engineering and manufacturing workflows to improve cost and throughput.
Engineering Strategy & Leadership
• Develop and execute a multi-year engineering strategy aligned with business objectives, product roadmap, and operational goals.
• Build and lead a high-performing engineering team; recruit, develop, and retain top technical talent.
• Establish a technical talent pipeline through structured development programs, mentorship, and succession planning.
• Define career paths and competency frameworks for engineering roles across the function.
• Foster a culture of engineering excellence, accountability, innovation, and cross-functional collaboration.
• Represent the engineering function in executive reviews, customer audits, and regulatory inspections.
• Manage departmental budgets, headcount planning, and capital expenditure forecasting.