Senior Catheter Engineer

Senior Catheter Engineer

This position will lead new catheter-related design projects for tier-1 customers, from concept to completion.

The ideal candidate will possess a strong background in medical device design and development, particularly with catheters, and will thrive in a customer-facing environment that demands both hands‑on R&D expertise and project management capabilities.

• Manage and lead new catheter design projects for tier-1 customers, ensuring successful execution from initiation to delivery
• Serve as the primary technical contact for customers, understanding their needs and translating them into innovative design solutions
• Develop and refine catheter designs, considering performance, manufacturability, cost, and regulatory requirements
• Oversee the entire project lifecycle, including planning, scheduling, resource allocation, risk management, and stakeholder communication
• Collaborate effectively with various global sites and internal interfaces (e.g., NPD, NPI, BD, QA) to ensure seamless project progression
• Contribute to the development of electro‑mechanical medical device assemblies, particularly those integrated with catheter systems
• Ensure all designs and project activities comply with relevant medical device regulations and quality standards
• Present project updates, design reviews, and technical solutions to internal teams and external customers

Education:
Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical field.

Experience:

• At least 7-10 years of progressive experience in the development of medical devices
• At least 4 years of demonstrated hands‑on experience in the design and development of catheters and delivery systems
  
  Experience with the development electro‑mechanical medical device assembly – advantage
• Proficiency in the development lifecycle of medical devices and catheters, from conceptual design all the way to verification and validation (V&V)
• Experience working in a quality‑controlled environment under ISO 13485, including documentation work
• Familiarity with global regulatory requirements for medical devices (e.g., FDA, CE Mark)
• Proven track record in managing complex design projects from concept to commercialization
• Experience working in a customer‑facing role, including technical presentations and relationship management – Advantage

• Strong proficiency in CAD software (e.g., Solid Works or other) for design and modelling
• Excellent project management skills, including planning, execution, and monitoring
• Exceptional communication and interpersonal skills, capable of effectively interacting with customers and internal cross‑functional teams across global sites
• Deep understanding of materials and manufacturing processes
• Problem‑solving aptitude with a keen eye for detail and a commitment to quality
• Ability to work independently and as part of a team in a fast‑paced, dynamic environment
• Willingness for frequent travel inside the US and abroad (EU, Israel, APAC)