FOR MORE THAN 80 YEARS, Natus has been working in collaboration with clinicians to deliver industry-leading neuro solutions that help providers more easily make sense of the body’s signals.
Engineered with input from those who have lived the care experience, our technology simplifies complex processes and improves accuracy and efficiency. There is a role for everyone who wants to be part of the innovative solutions at Natus Neuro.
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...
Be the People part of the Neuro Solution. Apply Today.
EEO Statement: Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status. This posting is for an existing vacancy.
Accessibility: Natus is committed to creating an inclusive environment that accommodates all individuals, including those with disabilities. We support the goals of the Accessibility for Ontarians with Disabilities Acts (AODA) and have established policies, procedures and practices which adhere to the accessibility standards set out in the AODA. Should you require any accommodation throughout the recruitment process please do not hesitate to contact our Human Resources Department.
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