Mechanical Design Engineer

Responsibilities:

• Design mechanical components for the implant and delivery system.
• Conduct mechanical simulations, prototyping, and tolerance analyses.
• Select materials, ensuring biocompatibility and performance.
• Collaborate with production to optimize designs for manufacturability and assembly.
• Create and maintain technical documentation, including drawings, BOMs, and specifications.
• Explore new materials, technologies, and design approaches.
• Ensure product compliance with medical device regulations (e.g., FDA, ISO 13485).
• Participate in design reviews and provide technical input.
• Remain informed on advancements in cardiovascular technologies and apply industry best practices.

Qualifications:

• Bachelor’s degree in Mechanical Engineering or a related field; Master’s degree preferred.
• 4+ years of experience in medical device development, preferably with a focus on transcatheter cardiovascular or implantable devices.
• Proficiency in CAD software and mechanical simulation tools.
• Hands-on experience with Nitinol shape forming and Pebax catheter manufacturing.
• Understanding of manufacturing processes, including injection molding, machining, and extrusion.
• Knowledge of ISO 13485, FDA, or MDR regulations is a plus.