Product Development Engineer, Smart Catheters
Listed on 2026-08-01
-
Engineering
Biomedical Engineer, Quality Engineering, Medical Device Industry, Mechanical Engineer
Job Description
Posted Tuesday, July 28, 2026 at 1:00 PM
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.
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.
Product DevelopmentDesign 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 & DocumentationExecute development activities in accordance with FDA, ISO 13485, and internal design control requirements.
Create and maintain:
- Design inputs and outputs
- Design reviews
- Verification protocols and reports
- Specifications and engineering drawings
- DHF documentation
Participate in design FMEA and risk analysis activities.
Verification & ValidationDevelop and execute test methods to characterize catheter performance.
Conduct bench testing for:
- Pressure accuracy
- Sensor stability
- Mechanical strength
- Flow characteristics
- Kink resistance
- Flexural performance
Analyze test data and prepare technical reports.
Support verification and validation activities required for regulatory submissions.
Manufacturing & Process DevelopmentCollaborate 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.
Cross-Functional CollaborationWork 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 (Solid Works, Creo, or equivalent).
- Strong analytical, technical problem-solving, and written/verbal communication skills.
- 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…
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