R&D Engineer – Clinical Applications
PI-Cardia
Summary
We are seeking a hands-on Research Engineer to serve as Pi-Cardia’s primary R&D representative in the U.S. This is a highly visible role at the intersection of engineering, clinical practice, and field support, with responsibility for patient-specific evaluations, imaging-based case planning, complaint investigations, and management of our U.S. R&D lab.
Job description
Position Overview
We are seeking a hands-on Research Engineer to serve as Pi-Cardia’s primary R&D representative in the U.S. This is a highly visible role at the intersection of engineering, clinical practice, and field support, with responsibility for patient-specific evaluations, imaging-based case planning, complaint investigations, and management of our U.S. R&D lab.
Key Responsibilities
- Act as the primary R&D representative in the U.S., working independently while maintaining close alignment with Israel-based teams
- Lead investigations of product- and patient-related complaints, including root cause analysis and documentation, in close collaboration with QA and cross-functional teams
- Represent R&D in patient evaluation and case review meetings, contributing engineering and product expertise
- Perform patient-specific anatomical assessments using imaging data (e.g., Echo, CT), including 3D modeling, 3D printing, and bench simulations to evaluate procedural feasibility and associated risks
- Support patient screening criteria refinement, based on product specifications, clinical experience, and accumulated data
- Overall responsibility and managing the R&D lab in the US facility
- Serve as a key liaison between field activities and R&D
- Support training of field teams and clinical users to ensure safe, consistent, and optimized device utilization
- Assist in the development and maintenance of training materials, and support ongoing training needs
Requirements
- B.Sc. in Biomedical/Mechanical Engineering or a related discipline
- 4+ years of experience in R&D / Research Engineering in the medical device industry, preferably in cardiovascular or interventional domains
- Hands-on experience leading or supporting product- and patient-related complaint investigations and root cause analysis
- Ability to work independently as a remote team member while maintaining strong communication and alignment with globally distributed teams
- Fast learner and self-sufficient
- Analytical and detail-oriented, with strong problem-solving capabilities
- Excellent documentation skills and ability to communicate results clearly and accurately
- Basic knowledge of regulatory and quality requirements applicable to medical devices (e.g., FDA, EU MDR, ISO standards)
- Strong collaboration skills with cross-functional teams (R&D, QA/RA, clinical, manufacturing)
- Experience with anatomical modeling, 3D printing, or simulation tools – an advantage
- Willingness to travel and work in clinical (hospital/cath lab) environments
Company overview
PI-Cardia is a medical device company specializing in innovative cardiovascular technologies focused on improving patient outcomes in structural heart disease. The company develops advanced solutions for minimally invasive cardiac procedures, with a particular emphasis on transcatheter interventions. PI-Cardia's technology platform addresses critical challenges in the treatment of aortic valve stenosis and other valvular heart diseases through novel device designs and procedural approaches. The company's research and development efforts concentrate on creating safer, more effective alternatives to traditional open-heart surgery, leveraging cutting-edge engineering and clinical insights. PI-Cardia operates at the intersection of cardiology, biomedical engineering, and interventional medicine, working to advance the field of structural heart interventions. Their product pipeline includes next-generation devices designed to enhance procedural precision, reduce complications, and expand treatment options for patients with complex cardiovascular conditions. The company collaborates with leading medical centers and clinicians to validate its technologies and ensure they meet the evolving needs of the cardiovascular care community.