Senior Medical Device R&D Engineer

Responsibilities

• Lead technical projects related to the design, development, testing, and manufacturing transfer of interventional catheter devices
• Perform hands-on prototyping, troubleshooting, and testing of medical devices
• Generate technical documentation in accordance with Design Control requirements
• Develop test methods, protocols, and reports for concept evaluations, V&V, and component qualification
• Generate and maintain Bills of Materials (BOMs), manufacturing process instructions, and risk management documentation
• Work directly with suppliers to support component development and resolve non-conformance issues
• Collaborate cross-functionally with manufacturing, quality, regulatory, and leadership teams

Requirements

• Bachelor’s degree in Mechanical Engineering
• Minimum 10 years of medical device R&D experience
• Strong working knowledge of ISO 13485 regulated Design Controls
• Hands-on catheter prototyping and testing experience
• Proficiency in SolidWorks (3D modeling and 2D drawings per ASME Y14.5)
• Knowledge of catheter manufacturing materials and processes (braiding, lamination, laser welding, adhesive bonding)
• Strong technical writing and documentation skills

Preferred Qualifications

• Catheter design and development experience
• Experience supporting FDA and/or Notified Body regulatory submissions
• Experience using cloud-based document control systems
• Demonstrated technical project leadership experience

About the Company

AngioSafe is a Bay Area start-up focused on improving healthcare through state-of-the-art vascular interventional catheter device design, development, and manufacturing.