Senior Catheter R&D Engineer - Lead Innovations

Inquis Medical, Inc.; Menlo Park, Northern (CA, KY); Hybrid; USD 160,000 - 210,000; Full time

Job summary

Inquis Medical, Inc. is seeking a Principal R&D Engineer to lead the full lifecycle of catheter-based product development from concept through commercialization, ensuring adherence to Design Control requirements and GMP guidance.

You will mentor engineers, collaborate with manufacturing, QA, and regulatory teams, and drive risk mitigation, verification, and production-scale improvements for large-bore catheter systems.

Qualifications

• Minimum 8 years of engineering experience.
• Significant hands-on catheter design experience.
• Experience designing large-bore catheters (>16F).
• Experience in Medical Device environments is a plus.
• 5 years minimum in Medical Device experience, taking designs from concept to manufacturing.

Responsibilities

• Lead the design, development, and documentation of catheter systems and subsystems.
• Translate user needs and requirements into robust technical solutions.
• Define verification and validation strategies and oversee testing and analysis.
• Collaborate with manufacturing to support process development and transfer.

Skills

Catheter design

Design controls

GMP compliance

Problem solving

SolidWorks

Communication

MS Office

Biocompatibility

Education

B.S. in Engineering

M.S. in Engineering

Tools

SolidWorks

Job description

Inquis Medical, Inc. is seeking a Principal R&D Engineer to lead the full lifecycle of catheter-based product development from concept through commercialization, ensuring adherence to Design Control requirements and GMP guidance.

You will mentor engineers, collaborate with manufacturing, QA, and regulatory teams, and drive risk mitigation, verification, and production-scale improvements for large-bore catheter systems.