Manufacturing Engineering Manager

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.

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

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

Salary Range - $165k - $180k