Senior R&D Engineer – Delivery Systems

HighLife; Irvine (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

HighLife Medical in California seeks a Senior R&D Engineer – Delivery Systems to design, build, test and refine transcatheter delivery systems and components. You will own delivery-system subsystems and work with cross-functional teams through concept to commercialization.

The role emphasizes hands-on mechanical design, rapid prototyping, DFMEA, bench testing, and collaboration with physicians, manufacturing and suppliers to bring robust, scalable solutions to the TMVR platform.

Qualifications

• Hands-on mechanical design experience in medical devices.
• Experience with catheter-based and transcatheter devices preferred.
• Experience through multiple phases of product development including concept to transfer.
• Strong CAD, tolerance analysis, and design-for-manufacturability knowledge.
• Ability to perform bench testing and root-cause analysis.

Responsibilities

• Design and develop transcatheter delivery systems and components.
• Lead development from early concept through verification, validation and transfer.
• Translate clinical needs into engineering specifications and practical design solutions.
• Develop catheter and delivery-system solutions addressing delivery, navigation, deployment, and system integrity.
• Own assigned components and collaborate across R&D, manufacturing, and suppliers.
• Create and maintain design verification documentation and DFMEA.
• Prototype, test, troubleshoot, and iterate concepts for robust manufacturability.

Skills

Mechanical design

Catheter development

Prototyping

DFMA

Root-cause analysis

Cross-functional

Manufacturing liaison

Troubleshooting

Education

Bachelor's in Mechanical Engineering

Master's in Mechanical Eng or related

Tools

SolidWorks

Job description

Principal R&D Engineer – Delivery Systems

About HighLife Medical

HighLife 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.

What You'll Make an Impact

• 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 workstreams 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 scalable manufacturing processes while maintaining design intent.
• Support supplier technical reviews, component development and qualification, and resolution of supplier-related engineering issues.
• Apply Design for Manufacturing and Assembly (DFMA) principles to improve product reliability, manufacturability, scalability, and cost.
• Support design transfer and manufacturing scale-up, including development of manufacturing specifications, fixtures, inspection methods, and acceptance criteria.
• Provide engineering support during prototype, pre-verification, design verification, validation, and clinical builds.
• Clearly communicate technical results, risks, recommendations, and next steps to R&D leadership and cross-functional teams.
• Manage assigned engineering priorities and deliverables in a fast-paced, entrepreneurial medical device environment.

What You'll Need

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or a related engineering discipline with 5+ years of relevant medical device development experience; or
• Master's degree in a related engineering discipline with 3+ years of relevant medical device development experience.
• Experience developing catheter-based, transcatheter, minimally invasive, or other complex interventional medical devices.
• Experience working through multiple phases of the medical device product development lifecycle, preferably including concept development, prototyping, design verification, validation, and/or design transfer.
• Strong hands-on mechanical design, prototyping, testing, and troubleshooting capabilities.
• Experience working within an FDA-regulated and/or ISO 13485 medical device development environment.

What Else We Look For

• Experience developing cardiovascular delivery systems is strongly preferred, particularly structural heart, transcatheter heart valve, electrophysiology, neurovascular, peripheral vascular, or similar catheter-based technologies.
• Experience developing large-bore catheter or implant delivery systems is highly desirable.
• Experience with delivery-system handles, deployment mechanisms, steering or articulation mechanisms, implant-loading systems, catheter shafts, or similar precision mechanical assemblies.
• Knowledge of catheter materials and construction methods, including polymers, metallic reinforcements, braids, coils, hypotubes, liners, jackets, and bonding technologies.
• Strong CAD skills; experience with SolidWorks or equivalent 3D CAD software preferred.
• Experience developing bench test methods and fixtures to characterize catheter and delivery-system performance.
• Ability to use engineering analysis, bench testing, and data to make sound design decisions.
• Strong root-cause analysis and troubleshooting capabilities.
• Demonstrated ability to independently execute technical assignments while knowing when to engage broader technical expertise.
• Ability to collaborate effectively with physicians, suppliers, consultants, technicians, and cross-functional teams.
• Strong attention to detail while maintaining an understanding of overall system performance and program objectives.
• Comfortable working in an environment where priorities evolve quickly and engineers are expected to take ownership of their designs and deliverables.

The Engineer We're Looking For

This is a hands-on engineering role, not primarily a project-management position.

We are looking for an engineer who enjoys spending time designing, building, testing, troubleshooting, and improving complex medical devices. The ideal candidate can independently take ownership of a delivery-system component or subsystem, work through technical challenges, and collaborate with the broader team to integrate those solutions into the overall TMVR system.

This individual will have the opportunity to make a meaningful technical contribution to the evolution of HighLife's TMVR technology and help develop the next generation of our transcatheter mitral valve delivery-system platform.

Compensation

HighLife 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.