Position Summary
We are seeking a talented and motivated Product 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:
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
