Process Development Engineer II – Catheters & Medical Devices

Confluent Medical Technologies, Inc.; Austin (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Confluent Medical Technologies, Inc. is seeking a Process Development Engineer II in Austin, TX to advance catheter manufacturing processes.

You will design process parameters, tooling, and semi-automated equipment, conduct DOE-based characterization, and lead validation activities (IQ/OQ/PQ) while collaborating across engineering teams to deliver high-quality medical devices. The role requires a BS or MS in a relevant field with 3–6+ years in medical device development, proficiency in

Qualifications

• BS in Materials, Mechanical, Bio Engineering or related field; MS preferred.
• 3–6+ years medical device development experience.
• Proficiency in SolidWorks; familiarity with design controls.
• Experience with IQ/OQ/PQ validation and protocol/report writing.
• Experience in catheter or medical device production equipment.
• Statistical analysis: DOE, ANOVA, Ppk.
• Leadership and cross-functional teamwork.

Responsibilities

• Work in a team to develop catheter manufacturing processes.
• Design new process parameters, tooling and methods for catheter manufacturing.
• Conduct Process Characterization Studies using DOE.
• Develop fixtures and semi-automated equipment for catheter assembly.
• Execute validation protocols (IQ/OQ/PQ).
• Perform process analysis, improvements and validation.
• Create reports and communications reporting engineering findings.
• Lead NPI, cost reduction, and revenue projects.
• Optimize processes to meet quality, build time, cost and yield targets.
• Generate work instructions, test methods, and visual standards.
• Mentor less experienced engineers.
• Participate in NCRs, CAPA, and root cause investigations.
• Plan and coordinate phases of engineering work on projects.
• Contribute to quality system improvements.

Skills

SolidWorks

Minitab

DOE

ANOVA

Design controls

Leadership

Attention to detail

Team player

Statistical analysis

Education

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

Master's degree preferred

Tools

SolidWorks

Minitab

Job description

Confluent Medical Technologies, Inc. is seeking a Process Development Engineer II in Austin, TX to advance catheter manufacturing processes.

You will design process parameters, tooling, and semi-automated equipment, conduct DOE-based characterization, and lead validation activities (IQ/OQ/PQ) while collaborating across engineering teams to deliver high-quality medical devices. The role requires a BS or MS in a relevant field with 3–6+ years in medical device development, proficiency in