Product Development Engineer, Smart Catheters

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:
  
  • 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

Canada Pay Transparency Clause
This posting is for an existing vacancy. The expected annual base salary for this position is $105K-135K CAD. This role may also be eligible for a company bonus or commission plan, as applicable to the position. Canadian work experience is not required. Automated or artificial intelligence-assisted tools may be used in the screening or assessment of applicants. Candidates who participate in an interview will be advised whether a hiring decision has been made within 45 days of the final interview, in accordance with applicable law.

Compensation and Benefits: Along with a competitive salary and bonus structure, Natus offers a comprehensive healthcare package that starts on your first day of employment, paid statutory holidays, 3 weeks' vacation and 7 sick days, RRSP Match, tuition reimbursement program eligibility and more...