Senior R&D Engineer Class II and Class III Interventional Devices

Position Summary

The Senior R&D Engineer is a highly technical individual contributor responsible for leading the design, development, prototyping, testing, and transfer of Class II and Class III interventional medical devices from concept through production. This position serves as a technical leader within the R&D organization, applying advanced engineering knowledge and hands-on expertise to develop complex catheter-based systems and other minimally invasive medical devices.

The Senior R&D Engineer will have demonstrated expertise in interventional catheter technologies, ePTFE, stents, catheter-based delivery systems, polymers, extrusion, braiding, bonding, coatings, and related medical device technologies. The position requires the ability to translate customer needs and clinical requirements into manufacturable product designs while working within a regulated medical device environment.

The Senior R&D Engineer leads technical development activities, mentors other engineers, provides technical direction on complex projects, and works closely with customers, Program Management, Quality, Manufacturing Engineering, Operations, and external suppliers to successfully deliver products that meet customer, regulatory, quality, cost, and schedule requirements.

• Lead the development of complex Class II and Class III interventional medical devices, with particular emphasis on catheter-based systems and minimally invasive delivery technologies.
• Serve as a technical subject matter expert for catheters, catheter assemblies, delivery systems, stents, ePTFE components, polymers, tubing, shafts, balloons, braiding, bonding, coatings, and related device technologies.
• Develop and engineer medical devices from initial concept through design transfer and production launch.
• Translate customer requirements, clinical needs, design inputs, and performance requirements into robust product designs.
• Lead hands‑on product and process development activities, including concept development, design iteration, prototyping, characterization, optimization, and troubleshooting.
• Design components and assemblies using Solid Works and other applicable engineering tools.
• Build and evaluate prototypes in a laboratory environment and develop practical solutions to complex technical challenges.
• Design, prototype, and construct catheter-based delivery systems and other disposable medical devices supporting applications across areas such as cardiology, peripheral vascular, neurology, structural heart, and urology.
• Apply knowledge of materials, mechanical properties, tolerances, interfaces, joining methods, and manufacturing processes to optimize device performance.
• Evaluate new materials, components, technologies, and suppliers to improve product performance, manufacturability, reliability, and cost.
• Lead technical problem‑solving and root‑cause investigations for product and process issues.

• Develop and maintain technical documentation required by the Aptyx Quality System and applicable design control processes.
• Develop design inputs, outputs, specifications, drawings, risk documentation, design reviews, and other product development documentation.
• Develop and execute Design FMEAs, process risk assessments, and other risk management activities.
• Develop feasibility, reliability, verification, and validation testing strategies for catheter systems and other medical devices.
• Develop and validate appropriate in‑vitro test methods, simulated‑use models, bench testing, and other performance evaluation methods.
• Support or lead verification and validation activities, including protocol development, test execution, data analysis, technical…