Product Development Engineer, Smart Catheters

Natus•Oakville, ON

13d•CA$105,000 - CA$135,000

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.
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.