Research Engineer - Patient Evaluation

Description

Location: Needham, MA (Greater Boston Area)

Work Arrangement: On-site, 5 days per week

About Pi-Cardia

Pi-Cardia is a growth-stage medical device company focused on developing innovative solutions for structural heart disease. Founded in Israel, with expanding operations in the United States, Pi-Cardia combines clinical excellence, technological innovation, and entrepreneurial agility. Our team works closely with leading physicians and global partners to bring meaningful, life-improving therapies to patients worldwide. We are building a high-performance organization that balances rapid growth with operational discipline, regulatory excellence, and a strong people-first culture.

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:

1. Act as the primary R&D representative in the U.S., working independently while maintaining close alignment with Israel-based teams
2. Lead investigations of product- and patient-related complaints, including root cause analysis and documentation, in close collaboration with QA and cross-functional teams.
3. Represent R&D in patient evaluation and case review meetings, contributing engineering and product expertise.
4. 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.
5. Supports patient screening criteria refinement, based on product specifications, clinical experience, and accumulated data.
6. Overall responsibility and managing the R&D lab in the US facility
7. Serve as a key liaison between field activities and R&D.
8. Support training of field teams and clinical users to ensure safe, consistent, and optimized device utilization.
9. Assist in the development and maintenance of training materials, and support ongoing training needs.

Requirements

1. B.Sc. in Biomedical/Mechanical Engineering or a related discipline
2. 4+ years of experience in R&D / Research Engineering in the medical device industry, preferably in cardiovascular or interventional domains
3. Hands-on experience leading or supporting product- and patient-related complaint investigations and root cause analysis
4. Ability to work independently as a remote team member while maintaining strong communication and alignment with globally distributed teams
5. Fast learner and self-sufficient
6. Analytical and detail-oriented, with strong problem-solving capabilities
7. Excellent documentation skills and ability to communicate results clearly and accurately.
8. Basic knowledge of regulatory and quality requirements applicable to medical devices (e.g., FDA, EU MDR, ISO standards).
9. Strong collaboration skills with cross-functional teams (R&D, QA/RA, clinical, manufacturing)
10. Experience with anatomical modeling, 3D printing, or simulation tools – an advantage
11. Willingness to travel and work in clinical (hospital/cath lab) environments

Annual base salary range: $150,000–$170,000, depending on experience and qualifications.

Equal Opportunity Statement

Pi-Cardia is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.