Staff R&D Engineer, Peripheral Vascular

This role is onsite in Irvine, California.

What You Will Do

• Lead concept-stage R&D projects focused on the development and integration of advanced catheter-based electromechanical systems and next-generation vascular technologies.
• Identify unmet clinical needs and translate physician and customer insights into innovative technical solutions and product concepts.
• Design, develop, modify, and verify catheter-based medical device components and subsystems with minimal supervision.
• Translate user needs into engineering specifications, system architectures, and subsystem-level designs.
• Lead prototyping, testing, and rapid iteration efforts to validate technical feasibility, design performance, and clinical value.
• Apply engineering principles and data-driven analysis to solve complex technical challenges involving catheter systems, sensing technologies, and electromechanical architectures.
• Partner closely with physicians, engineering teams, technology suppliers, and strategic collaborators to evaluate emerging technologies and inform future product development.
• Create and maintain engineering documentation, including Design History Files, risk assessments, and technical reports in compliance with design control procedures.
• Collaborate cross-functionally with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management teams to advance concepts from ideation through feasibility.
• Act as a technical leader and mentor, driving engineering best practices, supporting multiple innovation programs, and influencing technical strategy across the Concept Team.

What You Will Need

Required Qualifications

• Bachelor of Science in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Systems Engineering, or a related engineering discipline.
• Minimum four years of relevant work experience.
• Experience supporting catheter-based medical device development, including catheter technologies, components, design, testing, integration, or related product development activities.
• Experience designing and developing mechanical and/or electromechanical assemblies in a regulated product development environment.
• Demonstrated experience leading technical projects, prototype development efforts, feasibility studies, or cross-functional engineering initiatives.
• Experience translating user needs, clinical insights, or Voice of Customer feedback into engineering requirements and design specifications.
• Proficiency in creating engineering drawings and models using GD&T, CAD, and CAE tools, preferably SolidWorks.
• Familiarity with medical device design controls, risk management processes, and quality system requirements.

Preferred Qualifications

• Experience developing catheter-based electromechanical systems incorporating sensing, imaging, energy delivery, RF, PFA, IVUS, ultrasound, or similar technologies.
• Experience integrating sensors, electronics, wiring, or electrical components into catheter-based medical devices.
• Knowledge of materials, manufacturing processes, and Design for Manufacturability (DFM) principles.
• Experience supporting early-stage innovation, concept development, feasibility testing, and technology maturation programs.
• Working knowledge of the full medical device product development lifecycle, including concept generation, design controls, verification, validation, and commercialization.
• Proven ability to mentor engineers, influence technical direction, and serve as a technical lead within multidisciplinary engineering teams.