Senior Catheter R&D Lead - Imaging & Prototyping

Meet Life Sciences; San Jose (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Meet Life Sciences is seeking a Principal Catheter Engineer to lead disposable catheter development for the LIA platform. The role combines hands-on prototyping with design controls, V&V, and quality systems, while mentoring engineers and coordinating with manufacturing, quality, and regulatory teams.

You will drive design verification, risk analysis, and DHF maintenance, and steer RD projects toward manufacturable, scalable solutions for next-generation imaging catheters.

Qualifications

• Bachelor's or Master's in Biomedical, Mechanical, or Materials Engineering with 10+ years medical device experience.
• Hands-on prototyping of disposable catheter devices (bonding, reflow, multi-lumen assemblies).
• Expert SolidWorks CAD and large model management.
• Experience with DV/V&V protocols and drafting test methods.
• Familiar with QMS, dFMEA, pFMEA, URRA, and DHF structure.
• Leadership in RD projects and mentoring junior engineers/techs.
• Experience with sterilization and ISO 10993 testing.

Responsibilities

• Lead technical efforts for disposable catheter development and commercial ramp of LIA-1.
• Design, build, and test catheter prototypes with optical components; iterate for manufacturability.
• Author and execute design verification/validation protocols; draft tests with traceability.
• Own and maintain DHF and risk management documentation per ISO 14971 and QMS.
• Collaborate with Manufacturing, Quality, and Regulatory Affairs to transfer designs to production.
• Drive CAPA investigations for design- or process-related nonconformances.

Skills

Prototyping disposable devices

SolidWorks CAD

VV protocol drafting

QMS risk assessment (dFMEA/pFMEA/URRA)

RD project leadership

ISO 10993 familiarity

Design transfer to manufacturing

Education

Biomedical/Mechanical/Materials Eng (Bachelors or Masters)

Tools

DHF management tools

Risk management tools

Job description

Meet Life Sciences is seeking a Principal Catheter Engineer to lead disposable catheter development for the LIA platform. The role combines hands-on prototyping with design controls, V&V, and quality systems, while mentoring engineers and coordinating with manufacturing, quality, and regulatory teams.

You will drive design verification, risk analysis, and DHF maintenance, and steer RD projects toward manufacturable, scalable solutions for next-generation imaging catheters.