Process Development Engineer II - Medical Devices & Catheters

CONFLUENT MEDICAL TECHNOLOGIES INC.; Austin (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Confluent Medical Technologies in Austin, TX, is seeking a Process Development Engineer II to join our medical device team. You will design and develop process parameters, fixtures, and methods for complex catheters, and lead development projects to improve cost, quality, and throughput.

You will perform DOE-based characterization, validate protocols (IQ/OQ/PQ), generate clear work instructions, and mentor junior engineers while collaborating with cross-functional teams.

Qualifications

• BS in Materials, Mechanical, Bio Engineering or related field.
• MS preferred.
• 3–6+ years in medical device development; BS 1–4 with MS
• Proficiency in SolidWorks
• Familiarity with design control for medical devices
• Experience authoring design control documents
• Strong understanding of validation strategy (IQ/OQ/PQ)
• Hands-on experience with catheter or medical device production equipment
• Familiarity with catheter materials (Polyimide, PTFE, FEP, Pebax, nylons, urethanes)

Responsibilities

• Work in a team to advance catheter development.
• Develop and design new process parameters, tooling, and methods for manufacturing complex catheters.
• Perform Process Characterization Studies using DOE and statistical techniques.
• Design and develop fixtures and semi-automated equipment for assembly of complex catheters.
• Develop and execute validation protocols (IQ/OQ/PQ).
• Lead process improvements to meet quality, cost, and throughput targets.
• Create clear work instructions and test methods.
• Mentor less experienced engineers and collaborate cross-functionally.

Skills

SolidWorks proficiency

Design control knowledge

Statistical analysis (DOE, ANOVA)

Leadership skills

Problem solving

Attention to detail

Education

Bachelor of Science in Materials, Mechanical, Bio Engineering or related

Master's degree preferred

Tools

Minitab

Job description

Confluent Medical Technologies in Austin, TX, is seeking a Process Development Engineer II to join our medical device team. You will design and develop process parameters, fixtures, and methods for complex catheters, and lead development projects to improve cost, quality, and throughput.

You will perform DOE-based characterization, validate protocols (IQ/OQ/PQ), generate clear work instructions, and mentor junior engineers while collaborating with cross-functional teams.