Senior Process Engineering Technician

Confluent Medical Technologies; Austin (TX); On-site; USD 70,000 - 110,000; Full time

Job summary

Confluent Medical Technologies in Austin, TX seeks a Senior Process Engineering Technician to advance catheter manufacturing processes and tooling. You will work with engineering to optimize parameters, train staff, and develop clear work instructions and inspection standards.

The role requires hands-on, detail-oriented work with GMP and documentation, plus experience reading engineering drawings and using SolidWorks. Collaboration with engineers and technicians is essential for success.

Qualifications

• Minimum 8 years of directly related experience in catheter manufacturing.
• Hands-on experience with GMP, QA and process documentation.
• Ability to read engineering drawings and understand inspection requirements.
• Proficient in Excel for organizing and analyzing manufacturing data.

Responsibilities

• Learn new manufacturing processes, equipment, and technologies.
• Develop process parameters, tooling, and methods with engineering.
• Train technicians in assembly techniques, inspection methods and documentation.
• Collaborate with engineers to meet build time, cost and yield targets.
• Create work instructions, test methods, and visual standards.
• Support DOE studies to characterize processes and analyze data.
• Drive document changes through GMP and quality systems.
• Modify processes/equipment/tooling for new applications.
• Generate data summaries and basic BOMs for tooling/ equipment.

Skills

Mechanical aptitude

Analytical thinking

GMP/compliance

Reading engineering drawings

Education

High school diploma

Some college

AA or BS in related field

Tools

SolidWorks

3D printing (FDM/SLA)

Microsoft Excel

Job description

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

We are looking for a Senior Process Engineering Technician to join our team in Austin, TX. As a uniquely qualified candidate, you will:

Responsibilities:

• Self-motivated with a strong desire to learn new manufacturing processes, equipment, and technologies.
• Work closely with engineering to develop new process parameters, tooling, and methods for manufacturing.
• Work with and train other skilled technicians/operators in the assembly techniques, inspection methods and required documentation.
• Work with engineers to streamline process to meet manufacturing build time, cost, and yield targets.
• Research and leverage previous methods/processes/equipment/tooling on new applications.
• Optimize process parameters for a variety of equipment, such as hot boxes, braiders, coil winders, laminators, ovens, UV adhesive light welders, laser welders, and others.
• Verify components meet specification requirements through benchtop, functional, and load testing.
• Work with engineers to generate clear and concise work instructions, test methods, and visual standards.
• Support DOE’s to characterize process by collecting and analyzing data.
• Communicate issues to engineering for collaborative continuous improvements.
• Understands scope and expectations of study.
• Understands design requirements for tooling/equipment.
• Create spreadsheets to organize data, collect data, and graphically present data trends when applicable.
• Able to generate written summary of data with observations. Able to generate BOM with cost and lead time estimates for tooling/equipment.
• Provide input to technical discussions, able to communicate basic data evaluation and meaning.
• Troubleshoot moderately complex issues on new processes/methods/equipment/tooling and provide recommendations.
• Drive document changes through the quality management system
• Adjust and modify processes/methods/equipment/tooling for new applications
• Follow good manufacturing practices (GMP): line clearance, work instructions, lot travelers, etc.
• Design and modify simple fixtures, tooling, and work holding using SolidWorks.
• Create and maintain basic engineering drawings for fixtures, tooling, and manufacturing aids.
• Assist engineers with prototype builds, root cause investigations, and process development activities.
• Ability to independently identify problems, develop practical solutions, and implement process improvements with minimal supervision.

Education & Experience:

• High school diploma, some college and a minimum of 8 years of directly related experience. AA or BS a plus.
• Demonstrated ability with standard and challenging processes/methods/equipment/tooling related to catheter manufacturing.
• Able to troubleshoot moderately complex issues on existing processes/method/equipment/tooling
• Extremely hands on with strong mechanical aptitude.
• Strong attention to detail with the ability to identify process/documentation errors, and quality concerns.
• Ability to read engineering drawings and understand inspection requirements.
• Good written and verbal communication skills.
• Knowledge of polymer materials, catheter processing equipment, and manufacturing processes.
• Knowledge of good manufacturing principles (GMP)
• Attention to detail, Professional attitude, team player.
• Experience with SolidWorks preferred
• Experience creating simple manufacturing drawings and fixture designs preferred
• Experience with rapid prototyping methods such as FDM or SLA 3D printing is a plus.
• Proficient with Microsoft Excel for organizing, analyzing, and presenting manufacturing data.
• Ability to work independently while collaborating effectively with engineers, other technicians, and production personnel

Confluent Medical Technologies is an equal opportunity employer