Senior Catheter R&D Engineer — Large-Bore Systems

Inquis Medical, Inc.; Menlo Park (CA); On-site; USD 160,000 - 210,000; Full time

Job summary

Inquis Medical, Inc. in Menlo Park, CA seeks a Principal R&D Engineer to lead the design and development of catheter-based products from concept to commercialization, ensuring design controls compliance.

The role requires expertise in catheter design, architecture, verification/validation, and manufacturing scale-up, collaborating with R&D, quality, regulatory, and operations teams to deliver reliable, cost-effective devices.

Qualifications

• B.S. or M.S. in Engineering or relevant field preferred.
• Minimum 8 years engineering experience with catheter design.
• Experience designing large-bore catheters (>16F).
• Medical device startup experience a plus.
• 5+ years in medical device industry; concept to manufacturing.

Responsibilities

• Lead the design, development, and documentation of catheter systems and subsystems.
• Translate user needs and requirements into robust design solutions.
• Create specifications and drawings defining dimensional and performance criteria.
• Drive catheter architecture, material selection, coating strategy, and manufacturability.
• Define verification/validation strategies; oversee testing and analysis.
• Collaborate with manufacturing for process development and transfer.
• Investigate failures; drive CAPA and root-cause analysis.
• Provide technical leadership and mentoring to engineers.

Skills

Catheter design

Design controls

GMP / QMS

FMEA

SPC

DOE

SolidWorks

MS Office

Sterilization methods

Education

B.S. or M.S. in Engineering

Tools

SolidWorks 2005+

Job description

Inquis Medical, Inc. in Menlo Park, CA seeks a Principal R&D Engineer to lead the design and development of catheter-based products from concept to commercialization, ensuring design controls compliance.

The role requires expertise in catheter design, architecture, verification/validation, and manufacturing scale-up, collaborating with R&D, quality, regulatory, and operations teams to deliver reliable, cost-effective devices.