Principal R&D Engineer – Implant

Principal R&D Engineer – ImplantAbout HighLife MedicalHighLife 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 significant unmet needs of patients with mitral valve disease.We are seeking a Principal R&D Engineer – Implant to serve as a technical leader for the development of our current and next-generation transcatheter mitral valve implants.This position is ideal for an experienced structural heart engineer with deep, hands-on experience developing transcatheter bioprosthetic heart valves, including tissue valve design and processing, metallic or nitinol frame development, hydrodynamic performance testing, accelerated wear testing, and structural fatigue evaluation.The Principal R&D Engineer will work closely with R&D, Clinical, Quality, Regulatory, Manufacturing, suppliers, physician partners, and the Delivery Systems team to advance HighLife's TMVR implant technology.How You'll Make an ImpactServe as a technical lead for HighLife's transcatheter mitral valve implant, providing engineering leadership for current and next-generation implant development.Lead implant development activities including verification, validation, design transfer, clinical evaluation, and commercialization.Evaluate and optimize implant architectures, including frame geometry, anchoring/fixation, bioprosthetic tissue leaflets, skirts, coverings, sutures, sealing features, and implant interfaces.Apply direct knowledge of glutaraldehyde-treated and glutaraldehyde-stored bioprosthetic tissue valves, including the effects of processing, storage, handling, crimping, deployment, and environmental exposure on performance.Translate clinical needs, physician feedback, anatomy, procedural requirements, and system requirements into engineering specifications and implant design solutions.Lead optimization of nitinol frame designs, including geometry, material behavior, heat setting, strain limits, radial characteristics, fatigue performance, dimensional stability, and manufacturability.Optimize implant soft components including bioprosthetic tissue leaflets, skirts, coverings, sutures, sealing elements, and attachment methods.Evaluate relationships between leaflet design, frame geometry, tissue attachment, implant configuration, and hemodynamic performance.Evaluate implant/delivery-system interactions including crimping, loading, constraint, deployment, release, positioning, and post-deployment behavior.Develop clinically relevant bench models, fixtures, and test methods to characterize implant performance under representative anatomical and physiological conditions.Lead heart valve hydrodynamic testing using pulse duplicator systems, including test method development, pressure/flow measurements, effective orifice area, regurgitation, and high-speed assessment of valve opening and closure.Lead and execute accelerated wear testing (AWT), including test planning, sample preparation, execution, interim inspections, failure assessment, data analysis, and interpretation of durability results.Develop studies evaluating the effects of crimping, crimp duration, deployment, tissue condition, and implant geometry on valve durability and hydrodynamic performance.Lead valve frame fatigue evaluation, including physiologically relevant loading conditions, test strategy, fixture development, failure analysis, and interpretation of results.Partner with engineering resources on FEA, computational frame fatigue assessment, strain analysis, and durability modeling, correlating predictions with bench testing to establish design margins and identify failure modes.Design and execute engineering studies to characterize implant performance, understand design sensitivities, and support technical decisions.Lead development of engineering protocols, test methods, reports, product requirements, design inputs/outputs, specifications, risk analyses, and verification documentation.Lead and participate in design FMEAs, technical design reviews, and system-level risk management activities.Investigate complex bench, preclinical, and clinical observations using structured root-cause analysis and develop appropriate design or process improvements.Provide technical support for preclinical studies, physician evaluations, clinical cases, and clinical investigations.Partner with physicians, clinical and imaging specialists to translate anatomical and procedural challenges into improved implant designs.Work closely with the Delivery Systems team to ensure the implant and delivery system function as an integrated TMVR system.Partner with Manufacturing and suppliers to transition implant designs into reliable, repeatable, and scalable manufacturing processes.Communicate technical risks, results, recommendations, and development plans to R&D leadership and cross-functional teams.What You'll NeedBachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or related discipline with 8+ years of relevant medical device development experience, or Master's degree with 6+ years of relevant experience.Significant experience developing transcatheter or surgical bioprosthetic heart valves, with direct transcatheter heart valve development strongly preferred.Hands-on experience with bioprosthetic tissue heart valves, including tissue handling, processing, storage, inspection, assembly, and evaluation.Hands-on experience conducting and interpreting heart valve hydrodynamic testing using pulse duplicator equipment.Hands-on experience developing, executing, and interpreting accelerated wear testing (AWT) for bioprosthetic heart valves.Demonstrated experience with metallic or nitinol valve frame fatigue, including bench fatigue testing and/or computational fatigue analysis.Experience taking implantable medical devices through multiple phases of product development, preferably including verification, validation, design transfer, and clinical evaluation.Strong hands-on mechanical design, prototyping, testing, troubleshooting, and failure-analysis capabilities.What Else We Look ForDirect structural heart implant development experience, including TMVR, TAVR, TTVR, transcatheter valve repair, surgical heart valves, or related cardiovascular implant technologies.Deep understanding of bioprosthetic valve design and function, including leaflet geometry, tissue selection/processing, attachment, coaptation, opening/closing behavior, and failure modes.Experience with pericardial tissue and glutaraldehyde-treated/stored tissue valves.Strong understanding of heart valve hydrodynamics, including pressure gradients, effective orifice area, regurgitant fraction, flow characteristics, and high-speed leaflet imaging.Experience designing and executing pulse duplicator studies to characterize performance and investigate design changes or failure modes.Experience with accelerated wear testers and durability strategies for transcatheter or surgical bioprosthetic valves.Experience evaluating wear-tested valves for leaflet damage, abrasion, tears, delamination, suture damage, frame interaction, and other durability-related failure modes.Strong understanding of nitinol design principles, frame fatigue testing, fatigue FEA, strain-based durability assessment, and correlation of computational and physical testing.Experience evaluating effects of crimping and catheter-based delivery on tissue and frame durability.Familiarity with applicable ISO 5840 heart valve testing requirements.Strong CAD skills; SolidWorks or equivalent preferred.Strong understanding of medical device design controls, risk management, verification/validation, and design transfer.Ability to independently solve ambiguous, technically complex problems while moving effectively between hands-on engineering and technical leadership.The Engineer We're Looking ForWe are looking for a hands-on heart valve engineer and technical leader who can take ownership of the engineering development of HighLife's transcatheter mitral valve implant.The ideal candidate has direct experience developing bioprosthetic transcatheter heart valves and understands the relationship between tissue, frame design, valve hydrodynamics, durability, catheter-based delivery, anatomy, and long-term implant performance.This person should be equally comfortable designing an implant component in CAD, evaluating bioprosthetic tissue, setting up a valve in a pulse duplicator, reviewing high-speed leaflet imaging, evaluating accelerated wear testing, reviewing frame fatigue or FEA results, analyzing clinical observations, and leading formal design reviews.We are looking for someone who asks not only whether the valve meets its specifications, but why it performs the way it does, where its performance and durability margins are, and how the implant can be made better.This individual will serve as a key technical leader within HighLife R&D and have the opportunity to shape the evolution of our current TMVR implant and lead engineering development of our next-generation implant platform.CompensationHighLife Medical offers a competitive compensation package commensurate with experience and qualifications. For California candidates, the anticipated base salary will be provided in accordance with applicable California requirements. Final compensation will depend on experience, technical expertise, education, and other relevant qualifications. HighLife Medical is an equal opportunity employer.