Senior R&D Engineer

Responsibilities

• Lead the design and development of disposable medical devices from concept through commercialization
• Design catheter-based delivery systems and other disposable devices using Solid Works and rapid prototyping techniques
• Build and evaluate prototypes in a laboratory environment
• Develop innovative solutions across various therapeutic areas including cardiology, neurology, and urology
• Serve as the technical lead for development projects, ensuring objectives, timelines, and customer expectations are achieved
• Communicate project status, risks, and technical updates to customers and internal stakeholders
• Develop project schedules, resource plans, budgets, and technical strategies
• Mentor and guide engineers and technical team members throughout project execution
• Drive technical decision-making across the entire product lifecycle
• Develop feasibility, reliability, verification, and validation test plans
• Manage and support verification and validation activities, documentation, and reporting
• Develop pilot and manufacturing processes, equipment, and procedures
• Review manufacturing document changes for impact on design intent

• Bachelor's or master's degree in biomedical engineering, mechanical engineering, or related engineering discipline required
• 3+ years of medical device engineering experience required
• Experience developing disposable medical devices, catheters, or catheter‑based systems preferred
• Experience leading technical projects and coordinating cross‑functional teams
• Proficiency with Solid Works or equivalent CAD software
• Experience with design controls, verification, validation, and risk management activities
• Bachelor's degree in biomedical engineering
• Bachelor's degree in mechanical engineering
• Master's degree in biomedical engineering
• Master's degree in mechanical engineering