Manufacturing Engineering Manager

Zeus Industrial Products, Inc. • San Jose, CA

4d

About The Position

ESSENTIAL FUNCTIONS
Manufacturing & Production Support
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.
Process Development & Optimization
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.
Validation & Compliance
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.
Continuous Improvement & Operational Excellence
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.
Team & Resource Management
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.
Cross-Functional & Supplier Collaboration
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.
Financial & Strategic Responsibilities
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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed