Principal R&D Engineer – Delivery Systems

Principal R&D Engineer – Delivery SystemsAbout 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 the significant unmet needs of patients with mitral valve disease.We are seeking a Principal R&D Engineer – Delivery Systems to join our R&D team and play a key technical role in the development of current and next-generation transcatheter delivery systems. This position is ideal for an experienced medical device engineer who enjoys solving complex mechanical and catheter-based design challenges, working hands-on with prototypes, and taking products from concept through design verification and commercialization.The Principal R&D Engineer will work closely with R&D, Clinical, Quality, Regulatory, Manufacturing, suppliers, and physician partners to develop robust delivery-system technologies for structural heart applications.How You'll Make an ImpactServe as a technical leader for the design and development of transcatheter delivery systems, including catheter shafts, handles, deployment mechanisms, implant interfaces, and associated accessories.Lead development activities from early concepts and feasibility through design freeze, verification, validation, design transfer, and commercialization.Translate clinical needs, physician feedback, procedural requirements, and system-level requirements into practical engineering specifications and design solutions.Develop innovative mechanical and catheter-based solutions addressing challenges such as device delivery, navigation, positioning, deployment, retrieval, torque transmission, trackability, pushability, flexibility, and system integrity.Design and evaluate complex catheter assemblies, delivery-system components, mechanisms, fixtures, and prototypes using sound engineering principles and first-principles analysis.Apply strong understanding of catheter construction and manufacturing technologies, including polymer extrusion, laser-cut hypotubes, steerable catheter shafts, braiding/coiling, reflow, bonding, machining, injection molding, adhesives application, and related processes.Perform and guide CAD design, tolerance analysis, material selection, component specification, drawing development, and design-for-manufacturability activities.Rapidly develop prototypes and conduct bench testing to evaluate design concepts and drive iterative improvements.Lead development of engineering protocols, test methods, reports, and design verification documentation.Develop and maintain product requirements, design inputs/outputs, engineering specifications, risk analyses, drawings, test methods, and other design-control documentation.Lead and participate in design FMEAs, use-related risk assessments, technical design reviews, and system-level risk management activities.Investigate complex technical issues and device performance observations using structured root-cause analysis and develop appropriate design or process improvements.Provide technical support for preclinical studies, physician evaluations, clinical cases, and investigation of device or procedural observations as appropriate.Partner closely with physicians, clinical specialists, and internal stakeholders to understand procedural challenges and identify opportunities for improved device performance and usability.Work closely with Manufacturing and suppliers to transition designs into reliable and scalable manufacturing processes while maintaining design intent.Support supplier selection, technical reviews, component qualification, and resolution of supplier-related engineering issues.Apply Design for Manufacturing and Assembly (DFMA) principles throughout development to improve reliability, manufacturability, scalability, and cost.Support design transfer and manufacturing scale-up, including development of manufacturing specifications, fixtures, inspection methods, and acceptance criteria.Provide technical leadership during prototype, pre-verification, design verification, validation, and clinical builds.Effectively communicate technical risks, results, recommendations, and development plans to R&D leadership and cross-functional teams.Balance multiple priorities and make sound engineering decisions in a fast-paced, entrepreneurial medical device environment.What You'll NeedBachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or a related engineering discipline with 8+ years of relevant medical device development experience; ORMaster's degree in a related engineering discipline with 6+ years of relevant medical device development experience.Demonstrated experience developing catheter-based, transcatheter, minimally invasive, or other complex interventional medical devices.Demonstrated experience taking medical devices through multiple phases of the product development lifecycle, preferably including concept development, design freeze, verification, validation, and design transfer.Strong hands-on mechanical design and prototyping capabilities.Experience working within an FDA-regulated and/or ISO 13485 medical device development environment.What Else We Look ForStrong preference for experience developing cardiovascular delivery systems, including structural heart, transcatheter heart valve, electrophysiology, neurovascular, peripheral vascular, or similar catheter-based technologies.Direct experience developing large-bore catheter or implant delivery systems is highly desirable.Experience developing delivery-system handles, deployment mechanisms, steering or articulation mechanisms, implant-loading systems, or similar precision mechanical assemblies.Strong CAD skills; experience with SolidWorks or equivalent 3D CAD software preferred.Demonstrated ability to independently solve ambiguous and technically complex engineering problems.Strong root-cause analysis and troubleshooting capabilities.Ability to move effectively between hands-on engineering work and higher-level technical leadership.Ability to collaborate effectively with physicians, suppliers, consultants, and cross-functional teams.Strong attention to detail while maintaining focus on overall system performance and program objectives.Comfortable operating in an environment where priorities evolve quickly and engineers are expected to take significant ownership of their work.The Engineer We're Looking ForThis is not primarily a project-management role. We are looking for a hands-on technical leader and problem solver who enjoys designing, building, testing, and improving complex medical devices.Most importantly, this individual will have the opportunity to make a meaningful technical contribution to the evolution of HighLife's TMVR technology and help shape the next generation of our delivery-system platform.CompensationHighLife Medical offers a competitive compensation package commensurate with experience and qualifications. For California candidates, the anticipated base salary will be provided upon request. Final compensation will depend on experience, technical expertise, education, and other relevant qualifications.HighLife Medical is an equal opportunity employer.