Senior Process Development Engineer - MedTech Catheters

CONFLUENT MEDICAL TECHNOLOGIES INC.; Town of Florida (NY); On-site; 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, extrusion and balloon processes. You will collaborate across teams to drive validation, documentation and process improvements for high-volume medical devices.

The ideal candidate has 6+ years in medical device development, strong polymer science knowledge and hands-on CAD proficiency. This role emphasizes leadership, cross-site collaboration and delivering robust

Qualifications

• Bachelor or Master of Science in Mechanical or Bio Engineering.
• 6+ years of experience in medical device development.
• Authoritative in catheter, balloon and extrusion of medical devices.
• Experience with polymer testing methodologies (FTIR, DSC, MA).
• Proficient in medical grade polymers (Nylon 12, PBAX, Polyurethanes, PET).
• Experience with design control documents for medical devices.
• Proficient in AutoCAD to create balloon tooling drawings.
• Ability to work independently and support multi-sites.
• Strong SolidWorks and AutoCAD skills; Minitab experience.
• Leadership skills and cross-functional collaboration.

Responsibilities

• Work in a team environment to develop catheter, extrusion and balloon processes.
• Perform process analysis, improvements and process validation (IQ/OQ/PQ).
• Develop and execute validation protocols.
• Create reports and/or communications to report engineering findings.
• Lead new product introduction and cost reduction projects.
• Mentor less experienced engineers.
• Plan, schedule, and coordinate detailed phases of engineering work.

Skills

Catheters

Balloon development

Extrusion

Process validation

DOE

Minitab

AutoCAD

SolidWorks

Polymer science

Leadership

Education

Bachelor or Master of Science in Mechanical or Bio Engineering

Tools

AutoCAD

SolidWorks

Minitab

Job description

Confluent Medical Technologies in Laguna Niguel, CA, is seeking a Staff Process Development Engineer to advance catheter, extrusion and balloon processes. You will collaborate across teams to drive validation, documentation and process improvements for high-volume medical devices.

The ideal candidate has 6+ years in medical device development, strong polymer science knowledge and hands-on CAD proficiency. This role emphasizes leadership, cross-site collaboration and delivering robust