R&D Engineer - Med Device Manufacturing

Medical Device Engineer

A growing medical device organization is seeking a Medical Device Engineer to join their R&D team and support the design and development of advanced catheter-based technologies. This role is ideal for an Entry-Level Engineer through Senior Engineer-level professional who enjoys hands-on product development, solving complex engineering challenges, and contributing throughout the full product lifecycle from concept through commercialization.

The ideal candidate will have experience designing catheter-based medical devices, strong knowledge of materials and manufacturing processes, and the ability to collaborate cross-functionally with R&D, Quality, Manufacturing, and Operations teams.

Responsibilities

• Design and develop complex catheter-based medical devices and delivery systems
• Create CAD models, drawings, assemblies, and technical documentation using Solid Works or similar platforms
• Build and troubleshoot prototypes through hands-on testing and iterative development
• Support design verification activities, including test method development and mechanical testing
• Collaborate with manufacturing teams on DFM, process improvements, and production scale-up
• Maintain design documentation, risk files, and engineering records within a regulated medical device environment
• Support root cause investigations, product improvements, and technical problem solving

Qualifications

• Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field
• 3+ years of medical device product development experience (5+ preferred)
• Strong experience designing catheter-based medical devices, including areas such as:
• Multi-lumen shafts
• Braids, coils, and torque transfer systems
• Balloon integration
• Polymer and nitinol-based components
• Proficiency with 3D CAD software (Solid Works preferred)
• Hands-on prototype development, testing, and troubleshooting experience
• Understanding of medical device design controls, ISO 13485, ISO 14971, and FDA regulations

Preferred Experience

• Steerable or deflectable catheter systems
• Structural heart, cardiovascular, or therapeutic devices
• Catheter manufacturing processes including braiding, laser processing, bonding, reflow, tipping, and thermoforming
• Experience supporting transfer to manufacturing and commercialization

Opportunity Highlights

• Work on innovative catheter-based medical technologies
• Own projects throughout the full product development lifecycle
• Collaborate with talented engineering and cross-functional teams
• Make a direct impact on products that improve patient outcomes

Must be eligible to work in the United States without restriction and without the need for current or future sponsorship.