Product Development Engineer, Smart Catheters

Position Summary

We are seeking a talented and motivatedProduct Development Engineer to contribute to the design, development, and lifecycle management of next-generation Smart Catheter product line.  This role will support the development of minimally invasive, pressure-sensing medical devices used in critical care and neurodiagnostic environments.

The ideal candidate will have approximately 5 years of medical device engineering experience and demonstrated expertise in catheter-based products, sensor integration, polymer materials, manufacturing processes, and design controls. The engineer will collaborate closely with cross-functional teams including Systems Engineering, Quality, Regulatory Affairs, Clinical Affairs, Manufacturing Engineering, and Supply Chain to bring innovative products from concept through commercialization.

Essential Responsibilities

Product Development

• Design and develop pressure-sensing catheter systems for intracranial pressure monitoring applications.

• Generate and evaluate design concepts, prototypes, and product improvements.

• Develop catheter designs considering performance, biocompatibility, manufacturability, reliability, and cost objectives.

• Participate in system architecture discussions involving catheter mechanics, sensor technologies, signal transmission, and device integration.

• Support technology assessments and feasibility studies for new catheter materials, sensors, and manufacturing processes.

Design Control & Documentation

• Execute development activities in accordance with FDA, ISO 13485, and internal design control requirements.

• Create and maintain:

  • Design inputs and outputs

  • Risk management documentation

  • Design reviews

  • Verification protocols and reports

  • Specifications and engineering drawings

  • DHF documentation

• Participate in design FMEA and risk analysis activities.

Verification & Validation

• Develop and execute test methods to characterize catheter performance.

• Conduct bench testing for:

  • Pressure accuracy

  • Sensor stability

  • Mechanical strength

  • Flow characteristics

  • Kink resistance

  • Flexural performance

  • Environmental conditioning

• Analyze test data and prepare technical reports.

• Support verification and validation activities required for regulatory submissions.

Manufacturing & Process Development

• Collaborate with manufacturing teams to develop robust assembly and production processes.

• Support transfer of products from development into manufacturing.

• Investigate process variability and assist in root cause analysis activities.

• Evaluate suppliers and component performance.

• Participate in process qualification activities including IQ/OQ/PQ.

Cross-Functional Collaboration

• Work closely with Quality, Regulatory, Clinical Affairs, and Operations teams.

• Present technical findings in design reviews and project team meetings.

• Contribute to project planning, timelines, and risk assessments.

• Mentor junior engineers and technicians as appropriate.

Qualifications

Required

• Bachelor's degree in Mechanical, Biomedical, Materials, Chemical Engineering, or a related engineering discipline.

• 3-7 years of engineering experience, including at least 3 years in medical device development.

• Experience developing products within a regulated environment, including medical device design controls and risk management.

• Experience with catheter systems, disposable medical devices, polymer materials, precision assemblies, and design verification testing.

• Proficiency with CAD software (SolidWorks, Creo, or equivalent).

• Strong analytical, technical problem-solving, and written/verbal communication skills.

Preferred

• Experience developing pressure monitoring catheters, neurovascular/neurodiagnostic devices, interventional catheters, or sensor-enabled medical devices.

• Experience with MEMS pressure, fiber optic, or strain gauge sensor technologies.

• Working knowledge of ISO 13485, ISO 14971, IEC 60601, and FDA Quality System Regulations (21 CFR 820).

• Experience with catheter manufacturing processes such as extrusion, reflow, bonding, laser processing, and overmolding.

• Experience with statistical analysis tools including Minitab, JMP, or equivalent.

Key Competencies

• Engineering rigor and technical curiosity

• Design for manufacturability and root cause analysis

• Risk-based decision making and attention to detail

• Project execution and cross-functional collaboration

• Effective technical communication