Senior R&D Engineer – Delivery Systems

High Life Medical is a medical device company focused on transforming the treatment of structural heart disease through innovative transcatheter mitral valve replacement (TMVR) technologies. Our TMVR system is designed to address the significant unmet needs of patients with mitral valve disease.

We are seeking a Senior R&D Engineer – Delivery Systems to join our R&D team and contribute to the development of current and next-generation transcatheter mitral valve delivery systems.

This position is ideal for a hands-on medical device engineer who enjoys solving complex mechanical and catheter-based design challenges, building and testing prototypes, and working collaboratively to advance products from early concepts through design verification, validation, and commercialization.

The Senior R&D Engineer will work closely with R&D, Clinical, Quality, Regulatory, Manufacturing, suppliers, and physician partners to develop robust and intuitive delivery-system technologies for structural heart applications.

• Design and develop transcatheter delivery systems and associated components
  , including catheter shafts, handles, deployment mechanisms, implant interfaces, loading systems, and accessories.
• Support development activities from early concept and feasibility through design freeze, verification, validation, design transfer, and commercialization
  .
• Translate clinical needs, physician feedback, procedural requirements, and system-level requirements into engineering specifications and practical design solutions.
• Develop mechanical and catheter-based solutions addressing challenges such as device delivery, navigation, positioning, deployment, retrieval, torque transmission, trackability, pushability, flexibility, and system integrity
  .
• Take technical ownership of assigned components, subsystems, and engineering work streams while collaborating with other members of the R&D team on overall system development.
• Design and evaluate catheter assemblies, delivery-system components, mechanisms, fixtures, and prototypes using sound engineering principles and first-principles analysis.
• Apply knowledge of catheter construction and manufacturing technologies
  , including polymer extrusion, laser-cut hypotubes, steerable catheter shafts, braiding/coiling, reflow, bonding, machining, injection molding, adhesive processes, and related technologies.
• Perform CAD design, tolerance analysis, material selection, component specification, drawing development, and design-for-manufacturability activities
  .
• Rapidly develop prototypes and perform bench testing to evaluate design concepts, characterize device performance, troubleshoot technical issues, and drive iterative design improvements.
• Develop engineering protocols, test methods, reports, fixtures, and design verification documentation
  .
• Develop and maintain product requirements, design inputs and outputs, engineering specifications, drawings, risk analyses, test methods, and other design-control documentation.
• Participate in design FMEAs, technical design reviews, use-related risk assessments, and system-level risk management activities
  .
• Investigate technical issues and device performance observations using structured root-cause analysis and develop appropriate design or process improvements.
• Support preclinical studies, physician evaluations, clinical cases, and investigation of device or procedural observations as appropriate.
• Work directly with physicians, clinical specialists, and internal stakeholders to understand procedural challenges and identify opportunities to improve device performance and usability.
• Collaborate with Manufacturing and suppliers to transition designs into reliable and…