Research Engineer - Patient Evaluation

PI-Cardia • Boston, MA

23h • Onsite

About The Position

Pi-Cardia is a growth-stage medical device company developing solutions for structural heart disease. The company combines clinical excellence, technological innovation, and entrepreneurial agility, with operations in Israel and the United States.

The Research Engineer will be Pi-Cardia’s primary R&D representative in the United States, working at the intersection of engineering, clinical practice, and field support. The role includes patient-specific evaluations, imaging-based case planning, complaint investigations, and management of the U.S. R&D lab. The position is based in Needham, Massachusetts, and is on-site five days per week. The engineer will work independently while staying closely aligned with Israel-based teams and will serve as a liaison between field activities and R&D.

Requirements

• B.Sc. in Biomedical Engineering, Mechanical Engineering, or a related discipline.
• At least 4 years of R&D or Research Engineering experience in the medical device industry.
• 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 medical device regulatory and quality requirements, such as FDA, EU MDR, and ISO standards.
• Strong collaboration skills with cross-functional teams, including R&D, QA/RA, clinical, and manufacturing.
• Willingness to travel and work in clinical environments, including hospitals and catheterization labs.

Nice To Haves

• Experience in cardiovascular or interventional medical device domains.
• Experience with anatomical modeling, 3D printing, or simulation tools.

Responsibilities

• Act as the primary R&D representative in the United States, 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 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 such as echocardiography and CT, including 3D modeling, 3D printing, and bench simulations to assess procedural feasibility and associated risks.
• Support refinement of patient screening criteria based on product specifications, clinical experience, and accumulated data.
• Take overall responsibility for and manage the R&D lab at the U.S. facility.
• Serve as a liaison between field activities and R&D.
• Support training of field teams and clinical users to promote safe, consistent, and optimized device utilization.
• Assist in developing and maintaining training materials and support ongoing training needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level