Staff Process Development Engineer - MedTech Catheters

Confluent Medical Technologies, Inc.; Laguna Niguel (CA); On-site; USD 91,000 - 151,000; Full time

Job summary

Confluent Medical Technologies, Inc. is seeking a Staff Process Development Engineer to lead catheter, extrusion and balloon process development in Laguna Niguel, CA.

You will analyze processes, drive validations (IQ/OQ/PQ), and report results across cross-functional teams to enable scalable manufacturing. The role requires 6+ years in medical device development and strong polymer science knowledge, with hands-on design tools like AutoCAD, SolidWorks and Minitab.

Qualifications

• Bachelor's or Master's in Mechanical or Bio Engineering preferred.
• 6+ years of experience in medical device development.
• Experience with catheter, balloon and extrusion of medical devices.
• Familiar with polymer testing methods (FTIR, DSC, MA).

Responsibilities

• Work in a team to develop catheter, extrusion and balloon processes.
• Perform process analysis, improvements and validation.
• Develop validation protocols and report findings.
• Lead new product introduction, cost reduction, and projects.
• Create clear work instructions and test methods.
• Mentor junior engineers and support cross-site initiatives.
• Plan and coordinate detailed phases of engineering work.

Skills

Process development

Cross-functional

Validation IQ/OQ/PQ

DOE studies

Report writing

Leadership

Polymer science

Medical devices

Education

Bachelor's or Master's in Mechanical or Bio Engineering

Tools

AutoCAD

SolidWorks

Minitab

Job description

Confluent Medical Technologies, Inc. is seeking a Staff Process Development Engineer to lead catheter, extrusion and balloon process development in Laguna Niguel, CA.

You will analyze processes, drive validations (IQ/OQ/PQ), and report results across cross-functional teams to enable scalable manufacturing. The role requires 6+ years in medical device development and strong polymer science knowledge, with hands-on design tools like AutoCAD, SolidWorks and Minitab.