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PURPOSE OF JOB

The Principal R&D Engineer position works closely with the engineering teams to help design and develop the product. The Principal R&D Engineer is responsible for:

• 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.

MAJOR DUTIES AND RESPONSIBILITIES

• 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.
• Perform other duties as assigned.

EDUCATION REQUIREMENTS

• B.S. or M.S. in Engineering or relevant field is preferred.

EXPERIENCE REQUIREMENTS

• Minimum of 8 years of engineering experience.
• Demonstrated expertise in catheter design, with significant hands-on experience developing complex catheter systems.
• Required experience designing and developing large-bore catheters greater than 16F.
• Experience in the Medical Device Start-ups is a plus.
• 5 years minimum in Medical Device experience,
• 5 years minimum experience taking designs from concept to manufacturing.

REQUIRED SKILLS/ ABILITIES

• Deep expertise in catheter design and development for minimally invasive medical devices.
• Strong understanding of design controls, GMP, and applicable Quality System standards.
• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
• Excellent verbal and written communication skills are required.

• Demonstrated proficiency utilizing problem solving tools (i.e., FMEA, DOE, SPC, etc.) and application of statistical techniques is desired.
• Proficient in SolidWorks 2005+ software for machine design, tooling & fixturing and machined/ molded component design, both 3D modeling and 2D technical drawings.
• Must be comfortable with MS Office Package.
• Familiarity with the sterilization methods and biocompatibility testing is a plus
• Ability to perform activities to support product development, administration, manufacturing, and other company activities
• Expertise interfacing with R&D and manufacturing groups to train, build, and optimize device, design, and processes
• Excellent skills in device testing, fixture and tooling design and fabrication