Manufacturing Engineer

Manufacturing Engineer

This Manufacturing Engineer role focuses on supporting the production of commercial and non-commercial finished medical devices, with primary responsibility for maturing and stabilizing a newly launched neurovascular device. The engineer investigates and resolves daily production issues involving equipment and processes, identifies opportunities to improve cost, yield, and process efficiency, and turns improvement ideas into practical solutions. The role includes performing validation activities associated with process or material changes, exercising independent judgment in planning and organizing work, monitoring performance, and reporting status.

The engineer also provides technical information to development teams regarding manufacturing and processing techniques, materials, properties, and process advantages and limitations to support effective engineering planning.

Responsibilities:

• Provide daily support for products, processes, materials, and equipment to ensure production goals are consistently achieved.
• Build quality into all aspects of work by maintaining strict compliance with all applicable quality requirements and standards.
• Troubleshoot, repair, qualify, and validate new and existing equipment used to manufacture endovascular catheters.
• Prepare testing plans and technical justifications to support changes to processes, equipment, and materials.
• Determine the appropriate level of testing required for changes in alignment with internal procedures, customer expectations, and regulatory acceptance requirements.
• Collaborate with purchasing to optimize supply chains, recommend and support projects that reduce risk and cost, and contribute to long-term commodity strategies.
• Design, implement, and monitor Statistical Process Monitoring systems to maintain process control and improve performance.
• Monitor daily yields and act immediately to investigate and resolve issues in order to meet scrap reduction and output targets.
• Design, procure, and oversee fabrication of equipment, tooling, and fixtures needed for manufacturing operations.
• Perform troubleshooting on existing products and processes to resolve issues related to design, materials, or manufacturing methods.
• Prepare validation protocols and reports to clearly communicate test methods, results, and conclusions for process or material changes.
• Lead cross-functional project teams when required to drive manufacturing improvements and product support initiatives.
• Identify, implement, and manage equipment, labor, and cycle time requirements to support current and future production goals.
• Train operators and technicians or provide clear work direction to ensure proper use of equipment and adherence to processes.
• Perform or support Test Method Validations (TMVs) as needed to ensure measurement systems are robust and reliable.
• Identify and investigate manufacturing issues and non-conformances using root cause analysis, and disposition production material through the Non-Conforming Material Report (NCMR) process.
• Notify Quality Assurance and Quality Control promptly of any observed or reported product quality issues so that appropriate corrective actions can be taken.

Essential

Skills:

• At least 5 years of experience in manufacturing engineering within the medical device industry, ideally with a focus on catheter products.
• Hands-on experience in medical device manufacturing, including familiarity with catheter product design, manufacturing processes, and clinical applications.
• Strong knowledge in manufacturing processes and process engineering, including equipment improvement, troubleshooting, and validation.
• Demonstrated ability to drive process improvement and continuous improvement initiatives in a production environment.
• Experience with lean manufacturing and Six Sigma methodologies to optimize processes and reduce waste.
• Proficiency in validation activities, including equipment validation and process validation for medical device manufacturing.
• Practical experience with neurovascular or endovascular catheter manufacturing and associated equipment maintenance, repair, calibration, and troubleshooting.
• Ability to design for manufacturability,…