Principal R&D Engineer

Inquis Medical, Inc.•Menlo Park, CA

4d•$160,000 - $210,000

About The Position

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. This role involves conceptualizing, developing, and refining catheter-based systems and related subsystems for new products and product improvements. The engineer will serve as a subject matter expert in catheter design, including shaft construction, materials, tip design, braid/coil reinforcement, bonding, manufacturability, and performance optimization. A key responsibility is leading the development of large-bore catheter systems, including experience designing catheters greater than 16F. The role also requires applying hands-on expertise in hydrophilic (HP) coating implementation, process considerations, and performance evaluation, identifying potential product design risks and driving mitigation strategies, and initiating action to prevent recurrence of product nonconformities and verifying effectiveness of corrective actions. Additionally, the Principal R&D Engineer will support manufacturing scale-up, process development, and introduction of cost reduction and productivity improvements into production, as well as addressing product-related quality problems and supporting investigations, CAPA activities, and continuous improvement.

Requirements

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.
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.
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.
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

Nice To Haves

Experience in the Medical Device Start-ups is a plus.
Demonstrated proficiency utilizing problem solving tools (i.e., FMEA, DOE, SPC, etc.) and application of statistical techniques is desired.
Familiarity with the sterilization methods and biocompatibility testing is a plus

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.