Principal R&D Engineer

About the role

The Principal R&D Engineer works closely with engineering teams to help design and develop the product, leading the product development life cycle of a subsystem or full catheter-based product from concept through commercialization within Design Control requirements.

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
• Serve as a subject matter expert in catheter design, including shaft construction, materials, tip design, braid/coil reinforcement, bonding, manufacturability, and performance optimization
• Lead development of large-bore catheter systems, including experience designing catheters greater than 16F
• Apply hands-on expertise in hydrophilic (HP) coating implementation, process considerations, and performance evaluation
• Identify potential product design risks and driving mitigation strategies
• Initiate action to prevent recurrence of product nonconformities and verify effectiveness of corrective actions
• Support manufacturing scale-up, process development, and introduction of cost reduction and productivity improvements into production
• Address product-related quality problems and support investigations, CAPA activities, and continuous improvement
• Perform other duties as assigned

Qualifications

• B.S. or M.S. in Engineering or relevant field is preferred
• 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
• 5 years minimum in Medical Device experience
• 5 years minimum experience taking designs from concept to manufacturing
• Experience in Medical Device Start-ups is a plus

Skills

• 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
• 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 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

Pay

Compensation Range: $160,000—$210,000 USD