Manufacturing Engineering Manager

Zeus Industrial Products•San Jose, CA

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 SUPERVISORY RESPONSIBILITIES This position has direct supervisory responsibilities, including: 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 Qualifications QUALIFICATIONS Education & Experience 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. Technical Skills & Knowledge 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., SolidWorks, AutoCAD). Experience with Lean Manufacturing, Six Sigma, and statistical process control (SPC) methodologies preferred. Knowledge of GMP, GDP, and medical device regulatory requirements. Proficient with Microsoft Office and manufacturing data systems. COMPETENCIES To perform the job successfully, an individual should demonstrate: Values: Integrity, Accountability, Teamwork, Continuous Improvement Strong leadership presence in a production environment Excellent problem-solving and root cause analysis skills Ability to manage multiple priorities in a fast-paced manufacturing setting Effective communication across all levels of the organization Ability to influence cross-functional teams and drive change PHYSICAL DEMANDS AND WORK ENVIRONMENT Physical Demands Repetitive hand and finger motions associated with documentation and data analysis. Sedentary work with occasional lifting up to 10 pounds. Close visual acuity required for inspection, documentation review, and process evaluation. Work Environment Combination of office, laboratory, and manufacturing floor environments. Regular exposure to manufacturing areas requiring appropriate personal protective equipment (PPE) including gowns, gloves, hair/beard covers, safety glasses, hearing protection, and other site-specific requirements. TRAVEL Up to 20–25% travel may be required between company sites, supplier locations, and customer facilities as business needs dictate. OTHER DUTIES This job description is not intended to cover or contain a comprehensive listing of all activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change at any time with or without notice

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline is required.
Minimum of 5 years of experience in medical device manufacturing engineering, including people management or technical leadership experience.
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., SolidWorks, AutoCAD).
Knowledge of GMP, GDP, and medical device regulatory requirements.
Proficient with Microsoft Office and manufacturing data systems.
Integrity, Accountability, Teamwork, Continuous Improvement
Strong leadership presence in a production environment
Excellent problem-solving and root cause analysis skills
Ability to manage multiple priorities in a fast-paced manufacturing setting
Effective communication across all levels of the organization
Ability to influence cross-functional teams and drive change

Nice To Haves

Master’s degree is preferred.
Prior experience in catheter manufacturing or complex disposable medical devices is strongly preferred.
Experience in a contract manufacturing environment is highly desirable.
Experience with Lean Manufacturing, Six Sigma, and statistical process control (SPC) methodologies preferred.

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.
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