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Job Title: Head of Department R&D – Balloon PTCA Catheter Development ( Director) Location: Dehradun Job Type: Full-time Department: Research & Development ________________________________________ Job Summary: We are seeking highly motivated and skilled Director to guide R&D team in the design, development, and testing of Balloon PTCA (Percutaneous Transluminal Coronary Angioplasty) catheters. The successful candidate will be responsible for developing next-generation balloon catheters that meet regulatory, clinical, and performance requirements. This role requires expertise in medical device development, polymer materials, catheter manufacturing processes, and regulatory compliance. ________________________________________ Key Responsibilities: • Lead the design, development, and optimization of Balloon PTCA catheters from concept to commercialization. • Develop and execute design verification and validation (V&V) testing for balloon catheters. • Select and evaluate suitable materials, coatings, and polymers to enhance catheter performance. • Work closely with cross-functional teams including manufacturing, regulatory, and clinical teams to ensure product feasibility and compliance. • Develop prototypes, test methods, and specifications for catheter components and assemblies. • Analyze and troubleshoot product performance issues using DOE (Design of Experiments), FMEA (Failure Modes and Effects Analysis), and statistical methods. • Ensure compliance with ISO 13485, FDA, CE, and other relevant regulatory standards for medical device development. • Collaborate with suppliers to ensure quality and scalability of catheter production. • Document and maintain design history files (DHF), risk management files, and technical reports. ________________________________________ Qualifications & Experience: • Education: Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or a related field. • Experience: Min 8-15 years of experience in medical device R&D, preferably in balloon catheter design and development. • Strong knowledge of balloon forming, extrusion, bonding, and catheter assembly processes. • Hands-on experience with CAD software (e.g., SolidWorks), finite element analysis (FEA), and computational modeling. • Familiarity with balloon material properties, such as nylon, PET, and polyurethane. • Knowledge of medical device regulations including FDA 21 CFR Part 820, ISO 10993, and ISO 25539-1. • Proficiency in testing and characterization of catheter balloons (compliance, burst pressure, fatigue testing, trackability, etc.). • Strong problem-solving, analytical, and project management skills. • Excellent communication and teamwork abilities. ________________________________________ Preferred Qualifications: • Experience with balloon catheter technologies. • Understanding of angioplasty and interventional cardiology applications. • Experience with cleanroom environments and catheter manufacturing processes. • Knowledge of 3D printing and rapid prototyping for catheter components. ________________________________________ Why Join Us? • Work on cutting-edge interventional cardiology products. • Opportunity for career growth in a rapidly evolving medical device industry. • Collaborative and innovative work environment. • Competitive salary and benefits package. If you are passionate about medical device innovation and want to be part of a dynamic team developing life-saving technologies, apply today! Thank you! Assistant Talent Acquisition Manager Ana( Anamica) Anamica.kumari@nityo.com Desk Number- 6531522521 What’s App +6560275490/+917667035476 Show more Show less
