Sr. R&D Engineer

Job Overview

The Senior R&D Engineer will lead the design and development of innovative catheter-based medical devices, supporting products from initial concept through development, verification, validation, and commercialization. This role involves cross-functional collaboration, hands-on prototyping and testing, technical problem-solving, and compliance with medical device design controls and regulatory standards.

Key Responsibilities

• Design and develop new catheter-based medical devices, product enhancements, and design modifications.
• Collaborate with cross-functional teams throughout product development, design transfer, and commercialization.
• Identify project risks, troubleshoot technical challenges, and drive timely resolution of issues.
• Support prototype assembly and testing while developing assembly procedures and test instructions.
• Execute design control deliverables, including product specifications, verification and validation, risk assessments, and preclinical testing.
• Develop testing methods and evaluate product performance, system capabilities, and manufacturing processes.
• Provide technical guidance to technicians and temporary personnel, establishing priorities and supporting team collaboration.
• Maintain compliance with FDA regulations, GMP, QSR, MDR, and internal quality procedures.
• Communicate technical findings, project updates, and recommendations to stakeholders, including physicians, suppliers, and internal leadership.

Minimum Qualifications

• Bachelor’s degree in Engineering or a related technical discipline.
• 5+ years of medical device industry experience, ideally with catheter-based technologies.
• Strong analytical, communication, computer, and hands-on laboratory skills.
• Experience with SolidWorks and statistical analysis software, such as Minitab, preferred.
• Ability to work full-time on-site in Mountain View, California.