Senior Process Development Engineer, MedTech

Confluent Medical; Laguna Niguel, Northern (CA, KY); Hybrid; USD 91,000 - 151,000; Full time

Job summary

Confluent Medical Technologies in Laguna Niguel, CA is seeking a Staff Process Development Engineer to advance catheter, balloon and extrusion development. You will lead process analysis, validation (IQ/OQ/PQ), and design of robust processes while collaborating with multi-disciplinary teams across facilities.

The role requires 6+ years in medical device development, strong polymer science knowledge, and proficiency in AutoCAD/SolidWorks.

Qualifications

• 6+ years in medical device development.
• Authoritative in catheter, balloon, extrusion.
• Experience with polymer testing methods (FTIR, DSC, MA).
• Design control documents for medical devices.

Responsibilities

• Lead catheter, balloon, extrusion development projects.
• Perform process analysis, IQ/OQ/PQ, and validation.
• Develop and execute validation protocols.
• Create reports and communicate findings to teams.
• Collaborate with cross-functional teams across sites.
• Design process parameters, tooling, and methods for devices.
• Drive NPI, cost reduction, and revenue projects.
• Mentor junior engineers and perform design reviews.

Skills

Catheter development

Balloon development

Process validation

DOE

Report writing

Leadership

Cross-functional teamwork

Polymer science

Troubleshooting

Problem solving

Education

B.S. or M.S. in Mechanical or Biomedical/Bio Engineering

Tools

AutoCAD

SolidWorks

Minitab

FTIR

DSC

Job description

Confluent Medical Technologies in Laguna Niguel, CA is seeking a Staff Process Development Engineer to advance catheter, balloon and extrusion development. You will lead process analysis, validation (IQ/OQ/PQ), and design of robust processes while collaborating with multi-disciplinary teams across facilities.

The role requires 6+ years in medical device development, strong polymer science knowledge, and proficiency in AutoCAD/SolidWorks.