Description For Principal R&D Engineer

Product Development

‣ Leading the product development life cycle of a subsystem or full catheter-based product from concept through commercialization within Design Control requirements.
‣ Conceptualizing, developing, and refining catheter-based systems and related subsystems for new products and product improvements.
‣ Serving as a subject matter expert in catheter design, including shaft construction, materials, tip design, braid/coil reinforcement, bonding, manufacturability, and performance optimization.
‣ Leading development of large-bore catheter systems, including experience designing catheters greater than 16F.
‣ Applying hands-on expertise in hydrophilic (HP) coating implementation, process considerations, and performance evaluation.
‣ Identifying potential product design risks and driving mitigation strategies.
‣ Initiating action to prevent recurrence of product nonconformities and verifying effectiveness of corrective actions.
‣ Supporting manufacturing scale-up, process development, and introduction of cost reduction and productivity improvements into production.
‣ Addressing product-related quality problems and supporting investigations, CAPA activities, and continuous improvement.
‣ Lead the design, development, and documentation of catheter systems and subsystems for new and existing products.
‣ Translate user needs, clinical requirements, and engineering inputs into product concepts, design requirements, and robust technical solutions.
‣ Create component specifications, engineering drawings, and documentation that define dimensional, functional, and performance requirements to ensure quality and reliability.
‣ Drive catheter architecture development, including material selection, construction methods, coating strategy, and design for manufacturability.
‣ Define verification and validation strategies; develop written protocols in conjunction with appropriate functions; oversee and/or perform testing and analysis in support of new products or changes to existing products.
‣ Document results in report formats consistent with process requirements and design control expectations.
‣ Collaborate closely with manufacturing engineering to support process development, design transfer, pilot builds, and commercialization readiness.
‣ Investigate and analyze internal failures, process issues, and customer complaints for root cause; recommend and implement corrective and preventive actions as necessary.
‣ Perform trend analysis and generate reports to support product quality and reliability improvements.
‣ Provide technical leadership, mentorship, and training to engineers, technicians, and inspectors as needed.
‣ Work effectively with R&D, quality, regulatory, operations, and suppliers to build, optimize, and scale catheter designs and manufacturing processes.