Manufacturing Engineering Manager

Essential Functions

• Provide day-to-day manufacturing engineering support for catheter production, including troubleshooting yield, quality, and throughput issues.
• Serve as the escalation point for complex technical issues affecting safety, quality, delivery, or cost.
• Partner with Production, Quality, and R&D to ensure manufacturing processes consistently meet product specifications and customer requirements.
• Support introduction of new products into manufacturing, including line setup, pilot builds, and transition to sustained production.

• Lead development, optimization, and sustainment of manufacturing processes for catheter components and assemblies, including extrusion, braiding, lamination, bonding, coating, tip forming, and final assembly.
• Drive Design for Manufacturability (DFM) and Design for Assembly (DFA) feedback to R&D during product development and transfer activities.
• Develop, review, and approve manufacturing documentation including work instructions, routings, process flow diagrams, PFMEAs, and control plans.
• Identify and implement process improvements to increase yield, reduce cycle time, and lower cost of goods.

• Lead and support process validation activities (IQ/OQ/PQ) in accordance with FDA and ISO requirements.
• Ensure changes to validated processes follow change control and risk management requirements.
• Collaborate with Quality to investigate nonconformances, deviations, and CAPAs using robust root cause analysis methodologies.

• Champion continuous improvement initiatives using Lean, Six Sigma, and other problem‑solving methodologies.
• Analyze manufacturing data and metrics to identify trends, risks, and improvement opportunities.
• Support equipment upgrades, automation initiatives, and tooling improvements to enhance capacity, repeatability, and safety.
• Promote standardization and best practices across manufacturing lines and sites, where applicable.

• Lead, mentor, and develop a team of manufacturing engineers and technicians.
• Define staffing plans, assign priorities, and manage workloads to support production schedules and business objectives.
• Conduct hiring, onboarding, performance management, coaching, and development planning for direct reports.

• Work closely with Supply Chain and external suppliers to qualify materials, equipment, tooling, and contract services.
• Support supplier‑related investigations and process improvements as needed.
• Collaborate with Program Management, R&D, and Quality to ensure smooth product launches and ongoing manufacturing performance.

• Develop and manage the manufacturing engineering budget, including capital equipment, tooling, and external services.
• Support long‑term manufacturing strategy, capacity planning, and technology roadmap development.

• Hiring, training, and performance management of assigned employees.
• Establishing goals, providing regular feedback, and conducting performance reviews.
• Ensuring compliance with company policies, procedures, and safety requirements.

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline is required.
• Master’s degree is preferred.
• Minimum of 5 years of experience in medical device manufacturing engineering, including people management or technical leadership experience.
• Prior experience in catheter manufacturing or complex disposable medical devices is strongly preferred.
• Experience in a contract manufacturing environment is highly desirable.

• Strong understanding of medical device manufacturing processes and process validation requirements.
• Hands‑on experience with catheter‑specific manufacturing processes such as extrusion, braiding, bonding, coating, and assembly.
• Proficiency with manufacturing documentation systems and CAD tools (e.g., Solid Works, AutoCAD).
• Experience with Lean Manufacturing, Six Sigma, and statistical process control (SPC) methodologies preferred.
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