Principal TMVR Implant R&D Engineer

HighLife; Irvine (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

HighLife Medical, a leader in transcatheter mitral valve technology, seeks a Principal R&D Engineer – Implant to steer development of current and next‑generation TMVR implants. You will lead design, verification, and durability studies, integrating tissue, frame, and delivery-system interactions to meet clinical needs.

The role requires extensive experience with bioprosthetic heart valves, hydrodynamic testing, wear testing, and cross‑functional collaboration to translate biology into

Qualifications

• Extensive experience with transcatheter or surgical bioprosthetic heart valves.
• Hands-on tissue handling, processing, storage, and evaluation.
• Experience with pulse duplicator hydrodynamics and accelerated wear testing.
• Strong CAD skills and design controls, risk management, and documentation.

Responsibilities

• Provide technical leadership for current and next-generation TMVR implant development.
• Lead verification, validation, design transfer, clinical evaluation, and commercialization.
• Evaluate frame geometry, leaflet design, and tissue attachments for durability.
• Oversee hydrodynamic testing, wear testing, and FEA-based durability modeling.
• Translate clinical needs and physician feedback into engineering specs.
• Collaborate across R&D, Clinical, Quality, Regulatory, Manufacturing, and partners.

Skills

Technical leadership

Medical device development

Bioprosthetic valves

Fatigue testing

Pulse duplicator testing

FEA

CAD (SolidWorks)

Verification & validation

Delivery system interactions

Education

Bachelor's degree in Mechanical Engineering

Master's degree in a related field

Tools

SolidWorks

Job description

HighLife Medical, a leader in transcatheter mitral valve technology, seeks a Principal R&D Engineer – Implant to steer development of current and next‑generation TMVR implants. You will lead design, verification, and durability studies, integrating tissue, frame, and delivery-system interactions to meet clinical needs.

The role requires extensive experience with bioprosthetic heart valves, hydrodynamic testing, wear testing, and cross‑functional collaboration to translate biology into