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.