Key Responsibilities:

• Design plans, specifications, and prototypes for PTA/PTCA catheters.
• Conduct rigorous testing and analysis to ensure product performance and safety.
• Optimize materials and manufacturing processes to enhance quality and cost-effectiveness.
• Continuously improve designs while keeping up with industry trends.
• Conduct risk assessments and implement mitigation strategies.
• Collaborate with regulatory teams to meet FDA, ISO, and other industry standards.
• Manage R&D projects, ensuring adherence to timelines, budgets, and objectives.
• Provide technical guidance and mentorship to R&D technicians.
• Develop and validate testing protocols for product qualification.
• Generate detailed technical reports, CAD drawings, and project documentation.
• Perform benchmarking and risk analyses, including FMEA.

Requirements:

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or related field.
• 3-5 years in medical device industry, particularly in catheter research and development.
• Strong knowledge of Catheter design, development and manufacturing process.
• Strong project management skills
• Knowledge of medical device regulations and standards (ISO 13485, FDA, etc.).
• Excellent communication, leadership, and problem-solving skills.
• Ability to work effectively in a collaborative team environment.